Revision of 11/15/2017 Form # 249 Page 1 of 7 Pilot Clinical Trials in CKD Follow-Up Pill Dispensing and Counting Form # COMBINE
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1 Revision of 11/15/2017 Form # 249 Page 1 of 7 Pilot Clinical Trials in CKD Follow-Up Pill Dispensing and Counting Form # COMBINE This form is completed for all Protocol visits and for any extra follow-up visit at which pills are dispensed or counted. Participants should bring their pill bottles to all visits, whether pills will be counted or not. If the participant comes in before the end of the visit window and forgets the pills, ask the participant to come in again before the visit window ends and bring the pills. Don t complete this form until the pills were counted, pills were dispensed, or the visit window ends. The participant s opened bottles should not be re-dispensed at any follow-up visit. Follow local procedures for destruction of study medications that are not re-dispensed. Pill counts are expected at F1, F2, F3, and F12. F 1. Identification Number 2. Alphacode 3a.Visit 3b. Visit Number 4. Date pills counted or dispensed 5. Study Type (Month) (Week) (mm/dd/yyyy) 6. Visit Number Intended... F Follow-Up (F) Visits are 1, 2, 3, 6, 9, 11, 12. Code 99 for extra/non -protocol visits Lanthanum Carbonate/ 7. Study Medication Type Placebo 500 mg (Round white pills) Nicotinamide/ Placebo 750 mg (Football- shaped pills) a. Were any pills lost or ruined?* b. Were the pills counted (0=no, 1=yes) (if no, skip to j) c. # days between visits (calculated and displayed) d. # pills at end of previous visit e. Prescribed # of pills per day at end of last visit Depends on meal pattern/aes Depends on AEs f. # pills should have taken (# days between visits times prescribed # pills per day at end of last visit) g. Pill Count (# pills returned) h. # pills taken (# pills at end of previous visit minus # pills returned) i. Adherence Percent taken (#taken divided by #should have taken times 100%).. j. # returned unopened bottles that are redispensed (This should be 0 unless unopened bottles are redispensed) k. COMBINE Meal Pattern planned for after this visit** l. # new bottles dispensed m. # pills dispensed Must be a multiple of 45 C Must be a multiple of 80 n. Prescription type? *** o. Prescribed # of pills per day as participant leaves visit *Codes for any pills lost or ruined? 0=No, all is well; 1=Yes. (If any lost or ruined, don t count. Skip to Item j.) ** Codes for COMBINE Meal Pattern planned: 1=3 meals/day (prescribe 6); 2=2 meals, no snacks (prescribe 4), 3=2 meals, 1 snack (prescribe 5), 4=2 meals, 2 or more snacks (prescribe 6) *** Codes for Prescription type? 1=Standard per protocol for participant s COMBINE Meal Pattern and month of follow-up. 2=Cut in half per protocol due to hyper or hypophosphatemia. Document in item 8 below. 3=Cut in half per protocol due to platelets. Document in item 8 below. 4=Cut in half per protocol/mop for symptoms or other reasons. Document in item 8 below. 5=Cut in half or reduced due to local physician judgment. Document in item 8 below. 6=Discontinued due to local physician judgment. Document in item 8 below. 7=Cut in half or reduced due to participant preference/non-adherence. Document in item 8 below. 9=Discontinued due to participant preference/non-adherence. Document in item 8 below. 0=Prescription discontinuation required per protocol (or for end of study)
2 Page 2 of 7 8. a. Regarding Prescription type in Item 7n for Lanthanum/Lanthanum placebo column, what is the primary reason the L prescription is reduced or stopped?...,, (Codes are listed beginning on Page 3. Secondary and tertiary reasons may also be specified.) b. Regarding Prescription type in Item 7n for Nicotinamide/Nicotinamide placebo column, what is the primary reason the N prescription is reduced or stopped?...,, (Codes are listed beginning on Page 3. Secondary and tertiary reasons may also be specified.) 9. If item 7l column 1 indicates new Lanthanum Carbonate/Placebo (round white pills) were dispensed L Bottle Number 1 L Bottle number 2 L Bottle number 3 L Bottle number 4 L Bottle Number 5 L Bottle number 6 L Bottle number 7 L Bottle number 8 L Bottle Number 9 L Bottle number 10 L Bottle number 11 L Bottle number 12 L Bottle Number 13 L Bottle number 14 L Bottle number 15 L Bottle number 16* *Unless F3 (or F4) is early in the window AND F6 (or F9) is planned for late in its window, 15 bottles will be sufficient for dispensing at F3 and F If item 7l column 2 indicates new Nicotinamide/Placebo (football-shaped pills) were dispensed N Bottle Number 1 N Bottle number 2 N Bottle number 3 N Bottle number Date this form completed (mm/dd/yyyy)... / / 201. Username of person completing/reviewing completeness of this form... Clinical Center Use Only Date Form Entered (mm/dd/yyyy) / / Username of person entering this form
3 Page 3 of 7 CODES FOR PARTICIPANTS NO LONGER ATTENDING VISITS (Used for (the first) Form 249/250 when participant quits coming) Use the code below as the first reason but additional reasons should also be documented.) 100=Not attending visits; participant is not taking or has reduced study medications 101=Not attending visits; participant is not taking or has reduced study medications; has refused consent for any further follow-up. 102=Not attending visits; participant is not taking or has reduced study medications; site knows where participant lives but cannot communicate with participant, participant unresponsive 103=Not attending visits; participant is not taking or has reduced study medications; site no longer knows where the participant lives, participant completely lost. 104=Not attending visits; participant is not taking or has reduced study medications; has changed residence such that the COMBINE site is inaccessible 105=Not attending visits; participant is not taking or has reduced study medications; institutionalized, nursing home or rehabilitation center 106=Not attending visits; participant is not taking or has reduced study medications; incarcerated and is no longer attending visits; is allowing passive follow-up. Return from lost to follow up 115=Patient was previously lost to follow up but has now returned, restarting meds at a reduced dose CODES FOR PARTICIPANTS ATTENDING VISITS Codes related to participant burden 120=Participant is attending visits but not taking or has reduced study medications due to pill burden 121=Participant is attending visits but not taking or has reduced study medications due to complexity of the study (such as the number of visits and procedures) Codes related to participant concerns about detrimental effects of the medication 130=Participant is attending visits, not taking or has reduced study medications, concerned about the impact of medication on liver function, concerned for LFTs in others 131=Participant is attending visits, not taking or has reduced study medications, concerned about the impact of medication on renal function Codes related to non-gi symptoms on Forms 285/ =Bone fracture 141=Flushing (previously coded as 5 prior to 1/5/2016) 142=Hives (previously coded as 6 prior to 1/5/2016) 143=Bruising (previously coded as 1 prior to 1/5/2016) 144=Bleeding (previously coded as 2 prior to 1/5/2016) 145=Headache 146=Wheezing 147=Backache 148=Common cold 149=Loss of energy, feeling run down, fatigued 150=Drowsy, sleepy, can t stay awake 151=Dizziness 152=Insomnia
4 Page 4 of 7 Codes related to GI symptoms reported by the participant on Forms 285/ =UPPER ABDOMEN OR PIT OF STOMACH PAIN mild, 166=UPPER ABDOMEN OR PIT OF STOMACH PAIN moderate, 167=UPPER ABDOMEN OR PIT OF STOMACH PAIN severe, 168=HEARTBURN mild 169=HEARTBURN moderate 170=HEARTBURN severe 171=ACID REFLUX mild 172=ACID REFLUX moderate 173=ACID REFLUX severe 174=HUNGER PAINS mild 175=HUNGER PAINS moderate 176=HUNGER PAINS severe 177=NAUSEA mild 178=NAUSEA moderate 179=NAUSEA severe (previously coded as 4 prior to 1/5/2016) 180=RUMBLING in the stomach mild 181=RUMBLING in the stomach moderate 182=RUMBLING in the stomach severe 183=Stomach felt BLOATED mild 184=Stomach felt BLOATED moderate 185=Stomach felt BLOATED severe 186=BURPING mild 187=BURPING moderate 188=BURPING severe 189=PASSING GAS mild 190=PASSING GAS moderate 191=PASSING GAS severe 192=CONSTIPATION mild 193=CONSTIPATION moderate 194=CONSTIPATION severe (previously coded as 8 prior to 1/5/2016) 195=DIARRHEA mild 196=DIARRHEA moderate 197=DIARRHEA severe (previously coded as 3 prior to 1/5/2016) 198=LOOSE STOOLS mild 199=LOOSE STOOLS moderate 200=LOOSE STOOLS severe 201=HARD STOOLS mild 202=HARD STOOLS moderate 203=HARD STOOLS severe 204=URGENT NEED TO HAVE BOWEL MOVEMENT mild 205=URGENT NEED TO HAVE BOWEL MOVEMENT moderate 206=URGENT NEED TO HAVE BOWEL MOVEMENT severe 207=SENSATION OF NOT EMPTYING BOWELS mild 208=SENSATION OF NOT EMPTYING BOWELS moderate 209=SENSATION OF NOT EMPTYING BOWELS severe
5 Page 5 of 7 Codes related to other GI Symptoms 220=Vomiting Codes related to SAE, Illness, or Comorbidity Codes related to SAEs, Hospitalizations and Illness 230=Aftermath of a hospitalization SAE (details of the hospitalization will be on SAE Form 512) 231=Aftermath of a non-hospitalization SAE (details of the non-hospitalization SAE will be on SAE Form 522) Previous comorbid condition noted on the baseline Comorbidity Form =Myocardial infarction 241=Congestive heart failure 242=Angina/chest pain 243=Atrial fibrillation 244=Ischemia 245=Peripheral vascular disease 246=Cerebrovascular disease/stroke 247=COPD (excludes asthma) 248=Connective tissue disease 249=Peptic ulcer disease (excludes GERD) 250=Hemiplegia 251=Leukemia 252=Lymphoma 253=Multiple myeloma 254=Cancerous solid tumor 255=Diabetes mellitus 256=Liver disease 257=Hepatitis B 258=Hepatitis C 259=Gout 260=Needs a wheelchair to get around 261=Deaf 262=Legally blind Codes related to NEW comorbid condition/new diagnosis that was not noted on the baseline Comorbidity Form =Myocardial infarction New 271=Congestive heart failure New 272=Angina/chest pain New 273=Atrial fibrillation New 274=Ischemia New 275=Peripheral vascular disease New 276=Cerebrovascular disease/stroke New 277=COPD (excludes asthma) New 278=Connective tissue disease New 279=Peptic ulcer disease (excludes GERD) New 280=Hemiplegia New 281=Leukemia New 282=Lymphoma New 283=Multiple myeloma New 284=Cancerous solid tumor New
6 Page 6 of 7 285=Diabetes mellitus New 286=Liver disease New 287=Hepatitis B New 288=Hepatitis C New 289=Gout New 290=Loss of ability to ambulate/needs for a wheelchair to get around New 291=Loss of hearing New 292=Loss of vision New 293=Uremia NEW Codes for items not on Form 122 (Comorbidity Form) 300=Started dialysis 301=Had a renal transplant 302=Became pregnant 303=Death Code related to illness 310=Pneumonia 311=Shingles 312=Viral Syndrome Codes related to other symptoms 325=Muscle cramps 326=Sinus congestion 327=Change in perception of taste 328=Muscle weakness 329=Difficulty standing 330=Rectal bleeding Code related to trauma 350=Aftermath of trauma (trauma that was not a hospitalization or SAE): broken arm Codes related to lab values. (These are broken down in a way that allows the DCC to make sure the actual values are documented on study lab forms.) 400=Single measure of hypophosphatemia, central 401=Single measure of hypophosphatemia, local 402=More than one measure of hypophosphatemia, central 403=More than one measure of hypophosphatemia, local 404=More than one measure of hypophosphatemia, local and central 410=Single measure of hyperphosphatemia, central 411=Single measure of hyperphosphatemia, local 412=More than one measure of hyperphosphatemia, central 413=More than one measure of hyperphosphatemia, local 414=More than one measure of hyperphosphatemia, local and central 420=Single measure of low platelets, central 421=Single measure of low platelets, local 422=More than one measure of low platelets, central 423=More than one measure of low platelets, local 424=More than one measure of low platelets, local and central
7 Page 7 of 7 430=Single measure of low WBC, central 431=Single measure of low WBC, local 432=More than one measure of low WBC, central 433=More than one measure of low WBC, local 434=More than one measure of low WBC, local and central 440=Single measure of high AST, central 441=Single measure of high AST, local 442=More than one measure of high AST, central 443=More than one measure of high AST, local 444=More than one measure of high AST, local and central 450=Single measure of high ALT, central 451=Single measure of high ALT, local 452=More than one measure of high ALT, central 453=More than one measure of high ALT, local 454=More than one measure of high ALT, local and central 460=Single measure of high total bilirubin, central 461=Single measure of high total bilirubin, local 462=More than one measure of high total bilirubin, central 463=More than one measure of high total bilirubin, local 464=More than one measure of high total bilirubin, local and central 470=Single measure of high alkaline phosphatase, central 471=Single measure of high alkaline phosphatase, local 472=More than one measure of high alkaline phosphatase, central 473=More than one measure of high alkaline phosphatase, local 474=More than one measure of high alkaline phosphatase, local and central 480=Single measure of low neutrophils, central 481=Single measure of low neutrophils, local 482=More than one measure of low neutrophils, central 483=More than one measure of low neutrophils, local 484=More than one measure of low neutrophils, local and central 490=Single measure of high creatine kinase, central 491=Single measure of high creatine kinase, local 492=More than one measure of high creatine kinase, central 493=More than one measure of high creatine kinase, local 494=More than one measure of high creatine kinase, local and central (DCC will add code numbers on request for reasons that lead to a participant going off or reducing study medications)
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