Supplemental Information
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1 Supplemental Information SUPPLEMENTAL TABLE 5 Comorbidities and AEs by Patient ID: Cycle 1 5 BoNT-A; Cycle Sessions BoNT-A 5 Gastrostomy, swallowing problems, drooling, recurrent pain, spasticity medication, diabetes 6 Complex epilepsy, gastrostomy, reflux, recurrent respiratory infections, recurrent pain, vision 8 Epilepsy, gastrostomy, swallowing spasticity medication, hearing 9 Complex epilepsy, gastrostomy, reflux, spasticity medication, vision 13 Complex epilepsy, gastrostomy, reflux, recurrent pain, spasticity medication, vision 14 Gastrostomy, swallowing problems, drooling, recurrent respiratory infections, spasticity medication, vision 15 Complex epilepsy, gastrostomy, swallowing problems, spasticity medication, vision, Floppy, no vocalization, increased drooling Systemic Serious Possibly Withdrew: safety URTI at 1 wk Respiratory Mild Possibly LRTI with fever at 1 wk (symptoms before) Irritability and poor sleep at 3 mo, adm Systemic Serious Unrelated Cough with fever at 3 wk Increased Neurologic Moderate Unlikely seizures at 3 mo Chicken pox at 4 wk Systemic Moderate Unrelated URTI ear Respiratory Moderate Unrelated infection at 6 wk Seizure on day Neurologic Mild Possibly of BoNT-A Seizure at 2 wk Neurologic Mild Unlikely 17 Drooling Bruising Local Mild Definitely Bruising Local Mild Definitely and redness Rhinorrhoea and temp at 4 wk Respiratory Mild Possibly 18 Complex unstable epilepsy, gastrostomy, swallowing problems, recurrent pain, spasticity medication, vision, hearing Rhinorrhoea and cough at 4 mo Increased Neurologic Moderate Unlikely seizures at 6 wk SI1
2 SUPPLEMENTAL TABLE 5 Continued 22 Epilepsy, gastrostomy, swallowing recurrent pain medicated daily, spasticity medication, congenital heart disease, vision, 24 Recurrent pain, vision 26 Gastrostomy, swallowing problems, drooling, reflux, recurrent pain medicated daily, vision 27 Unstable epilepsy, gastrostomy, recurrent pain 28 Complex epilepsy, swallowing respiratory infections, recurrent pain, spasticity medication, vision 30 Complex epilepsy, swallowing pain medicated daily, spasticity medication, asthma, 31 Epilepsy, gastrostomy, swallowing recurrent pain, inflammatory bowel disease, vision 33 Complex epilepsy, drooling, recurrent pain, vision 34 Swallowing problems, reflux, recurrent pain, spasticity medication, vision 37 Gastrostomy, swallowing problems, drooling, spasticity medication, asthma 38 Drooling, recurrent respiratory infections, recurrent pain,, 39 Complex epilepsy, gastrostomy, reflux, vision LRTI at 6 wk Respiratory Moderate Possibly LRTI at 4 mo, adm Respiratory Serious Unlikely Bruising Local Mild Definitely URTI rhinorrhoea and cough at 3 wk Respiratory Mild Unlikely Bruising and rash Local Mild Definitely Withdrew surgery Weakness, gagging, vomiting, constipation, temp, seizure Systemic Moderate Probably Cough and Respiratory Mild Possibly Bruising Local Mild Definitely cold at 1 wk Seizure Neurologic Serious Unlikely Seizure Neurologic Serious Unlikely (associated (associated UTI) at 5 d, adm UTI) at 8 d, adm URTI cough Respiratory Mild Unlikely and cold (symptoms prior) UTI at 7 wk, adm Renal Serious Unrelated Ulcerative colitis at 3 mo, adm GI Serious Unrelated Bruising Local Mild Definitely URTI and Respiratory Mild Unlikely conjunctivitis at 6 wk LRTI URTI rhinorrhoea at 2 wk Increased seizures at 3 mo Respiratory Mild Unlikely Withdrew surgery Neurologic Moderate Unlikely Bruising Local Mild Definitely SI2 EDWARDS et al
3 SUPPLEMENTAL TABLE 5 Continued 40 Complex epilepsy, drooling, recurrent pain, vision, hearing, 41 Complex unstable epilepsy, gastrostomy, swallowing respiratory infections, recurrent pain, vision Increased saliva at 1 wk Systemic Moderate Possibly Increased seizures at 2 wk Systemic Moderate Probably URTI, floppy, increased drooling for 4/5 d after BoNT-A Neurologic Moderate Unlikely There was no participant ID 4. Adm, admission to hospital; GI, gastrointestinal; LRTI, lower respiratory tract infection; URTI, upper respiratory tract infection;, no reported AE. SI3
4 SUPPLEMENTAL TABLE 6 Comorbidities and AEs by Patient ID: Cycle 1 5 Sham, Cycle 2 5 BoNT-A 31 1 Complex unstable epilepsy, drooling, recurrent pain, vision 2 Epilepsy, gastrostomy, swallowing pain, spasticity medication, asthma 3 Complex epilepsy, drooling, recurrent pain medicated daily, 7 Complex unstable epilepsy, gastrostomy, swallowing spasticity medication, asthma, vision 10 Epilepsy, gastrostomy, swallowing, hearing 11 Complex epilepsy, drooling, vision 12 Complex epilepsy, gastrostomy, reflux, recurrent respiratory infections, recurrent pain, spasticity medication, asthma, vision 16 Complex epilepsy, gastrostomy, recurrent pain, spasticity medication 19 Epilepsy, gastrostomy, swallowing problems, drooling, spasticity medication, vision, Withdrew: surgery Hallucinating, teary, upset within timing of fentanyl Systemic Moderate Probably Bruising Local Mild Definitely Short generalized seizures Neurologic Moderate Unlikely at 3 4 mo LRTI and conjunctivitis at 4 mo Prolonged seizure in procedure Neurologic Serious Probably Seizure postprocedure, adm Neurologic Serious Possibly URTI ear infection, cough at 2 d (symptoms before BoNT-A) Vomiting and diarrhea (change GI Mild Unlikely of feed) SI4 EDWARDS et al
5 SUPPLEMENTAL TABLE 6 Continued 20 Epilepsy, gastrostomy, swallowing problems, reflux, recurrent pain, 21 Complex epilepsy, gastrostomy, swallowing problems, reflux, recurrent pain medicated daily,, 23 Complex epilepsy, drooling, 25 Complex epilepsy, gastrostomy, reflux, recurrent respiratory infections, recurrent pain medicated daily, spasticity medication, vision, hearing 29 Drooling, recurrent pain, spasticity medication, vision, 32 Epilepsy, gastrostomy, swallowing problems, reflux, recurrent respiratory infections, recurrent pain, spasticity medication, hearing 35 Complex epilepsy, gastrostomy, reflux, recurrent pain, spasticity medication, vision, hearing 36 Drooling, spasticity medication, vision 42 Gastrostomy, swallowing problems, drooling, reflux, spasticity medication, vision Focalseizuresonnightof procedure Neurologic Moderate Probably Button leakage, anal fissure, fever, lethargy URTI at 3 d (symptoms before BoNT-A) GI Moderate Unlikely Respiratory Moderate Possibly Increased drooling 1 4 wk Systemic Moderate Probably URTI rhinorrhoea and cough at 2 wk LRTI rhinorrhea, cough, tachypnea at 6 wk Loose stool at 2 4 d GI Mild Probably Decreased neck control, increase saliva, urinary incontinence at 2 10 d LRTI cough and chest infection at 2 3 wk after BoNT-A LRTI chest infection at 3 mo after BoNT-A LRTI cold and chest infection (symptoms before BoNT-A) Increased drooling (symptoms before BoNT-A) LRTI chest infection (symptoms before BoNT-A) Respiratory Mild Unlikely Respiratory Moderate Possibly Systemic Moderate Probably Systemic Mild Unlikely URTI croup, adm Respiratory Serious Possible Vomiting and diarrhea at GI Serious Unlikely 16 wk, adm Seizure on day of BoNT-A Neurologic Moderate Possibly Reflux, irritable at 3 7 d Systemic Mild Possibly There was no participant ID 4. Adm, admission to hospital; GI, gastrointestinal; LRTI, lower respiratory tract infection; URTI, upper respiratory tract infection;, no reported AE. SI5
6 APPENDIX 1 CARE AND COMFORT PREPROCEDURE HEALTH CHECK To be completed by Injecting Doctor and Filed in Chart. Has your child/does your child... In the past week? Describe below. In the past 3 months? Describe below. Been generally well? Had a cough or cold or respiratory infection? Had a fever/raised temperature? Had any diarrhea or vomiting? Had contact with anyone who has been unwell or with an infection? Had any seizures? Normal or altered pattern? Please describe. Had any visits to the doctor or admissions? Had any immunizations? Had any change in medications? Please list current medications, dose and frequency. Had any use of Panadol or other? Had any change in diet? Had any change in swallowing drooling? Please describe normal pattern. Had any stridor? Normal or altered pattern? Had any other medical concern? Had any previous adverse reaction to botulinum toxin type A or analgesia? Have any allergies (eg, to iodine, tape)? SI6 EDWARDS et al
7 APPENDIX 2 EVALUATION OF THE EFFECTS OF BONT-A INJECTIONS IN IMPROVING EASE OF CARE AND INCREASING COMFORT IN CHILDREN WITH MARKED CEREBRAL PALSY: A RANDOMIZED CONTROLLED TRIAL DOCUMENTATION OF AES This form must be completed for each trial participant at each assessment point. It is not necessary for the clinician documenting AEs to fully determine whether the events to be documented are solely associated with the use of BoNT-A or are coincidental with treatment. All serious AEs will be reviewed by a safety committee separate from the study investigators. Participant No: Did It Occur? Date of Review: Assessed by: AE Description When Started When Finished Severity Advice/Treatment Sought Related to fentanyl Respiratory depression Apnea Muscle rigidity Myoclonic movements Bradycardia Temporary local weakness Generalized weakness (change in head or trunk control) Flulike symptoms (cough, cold, fever, etc) Pain/bruising at injection site Allergic reaction/rash Change in continence Bladder Bowel Difficulty with respiratory function/ breathing Respiratory infection New/increased stridor Difficulty with swallowing (new or increased) Increased difficultly vocalizing Increased seizures Increased use of anticonvulsants Death Please note the severity of the event using the following definitions: Mild: awareness of sign or symptom but easily tolerated; Moderate: discomfort sufficient to cause interference with usual activity; Serious: Incapacitating with inability to work or do usual activity, any event that results in hospital admission or medical intervention; Not applicable: In some cases, an adverse event may be an all or nothing finding that cannot be graded. Finding to be forwarded to the external safety committee? Yes or No SI7
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Review of Systems: 0-1 year old Constitution neg Eyes neg GI neg Neurological neg + Activity Change - + Eye Discharge - + Reflux - + Facial Asymmetry - + Appetite Change - + Eye Redness - + Vomiting -
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