Trial Outcomes & Findings for Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) (NCT NCT01197378)
NCT ID: NCT01197378
Last Updated: 2024-12-27
Results Overview
Drug-related adverse events (AEs) are AEs the investigator assessed as having relation to drug of 'possibly', 'probably' or 'definitely'. The severity of AEs was categorized according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 as follows: * Mild (Grade 1): experience is minor and does not cause significant discomfort to subject or change in activities of daily living (ADL); subject is aware of symptoms but symptoms are easily tolerated; * Moderate (Grade 2): experience is an inconvenience or concern to the subject and causes interference with ADL, but the subject is able to continue with ADL. * Severe (Grade 3): experience significantly interferes with ADL and the subject is incapacitated and/or unable to continue with ADL * Life-threatening (Grade 4): experience that, in the view of the Investigator, places the subject at immediate risk of death from the event as it occurred.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
From first dose of study drug to 7 days after the last dose; median duration of treatment was 1461 days.
Results posted on
2024-12-27
Participant Flow
Initially, only patients who completed the previous Phase III Study RP103-03 (NCT01000961) were enrolled in this extension study. As of 27 September 2011, enrollment was opened up to additional participants, including children who were less than 6 years of age and kidney transplant subjects who qualified based on the inclusion/exclusion criteria.
Participant milestones
| Measure |
Cysteamine Bitartrate
Cysteamine bitartrate delayed-release capsules were administered twice daily for up to 96 months.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
Received Treatment
|
59
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Cysteamine Bitartrate
Cysteamine bitartrate delayed-release capsules were administered twice daily for up to 96 months.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)
Baseline characteristics by cohort
| Measure |
Cysteamine Bitartrate
n=59 Participants
Cysteamine bitartrate delayed-release capsules were administered twice daily for up to 96 months.
|
|---|---|
|
Age, Continuous
|
10.9 years
STANDARD_DEVIATION 6.00 • n=5 Participants
|
|
Age, Customized
≤ 6 years
|
13 Participants
n=5 Participants
|
|
Age, Customized
> 6 to ≤ 12 years
|
25 Participants
n=5 Participants
|
|
Age, Customized
> 12 to ≤ 21 years
|
19 Participants
n=5 Participants
|
|
Age, Customized
> 21 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug to 7 days after the last dose; median duration of treatment was 1461 days.Population: All participants who received at least 1 dose of cysteamine bitartrate.
Drug-related adverse events (AEs) are AEs the investigator assessed as having relation to drug of 'possibly', 'probably' or 'definitely'. The severity of AEs was categorized according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 as follows: * Mild (Grade 1): experience is minor and does not cause significant discomfort to subject or change in activities of daily living (ADL); subject is aware of symptoms but symptoms are easily tolerated; * Moderate (Grade 2): experience is an inconvenience or concern to the subject and causes interference with ADL, but the subject is able to continue with ADL. * Severe (Grade 3): experience significantly interferes with ADL and the subject is incapacitated and/or unable to continue with ADL * Life-threatening (Grade 4): experience that, in the view of the Investigator, places the subject at immediate risk of death from the event as it occurred.
Outcome measures
| Measure |
Cysteamine Bitartrate
n=59 Participants
Cysteamine bitartrate delayed-release capsules were administered twice daily for up to 96 months.
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events
Any adverse event
|
58 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Adverse events related to study drug
|
37 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Adverse events ≥ Grade 3
|
24 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Serious adverse events
|
32 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Adverse events leading to discontinuation
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 (predose) and Month 6, Years 1, 1.5, 2, 3, 4 and 5 at 0.5 hours post-dosePopulation: The Pharmacokinetic/Pharmacodynamic (PK/PD) Population includes all participants who had at least one PK/PD measurement. Day 1 results only include participants who did not complete Study RP103-03.
Plasma cysteamine concentration was determined using methods employing Hydrophilic Interaction Liquid Chromatography (HILC) high pressure liquid chromatography (HPLC) tandem mass spectrometry (HPLC-MS/MS).
Outcome measures
| Measure |
Cysteamine Bitartrate
n=59 Participants
Cysteamine bitartrate delayed-release capsules were administered twice daily for up to 96 months.
|
|---|---|
|
Trough Plasma Cysteamine Concentration
Day 1
|
0.17 mg/L
Standard Deviation 0.093
|
|
Trough Plasma Cysteamine Concentration
Month 6
|
0.29 mg/L
Standard Deviation 0.613
|
|
Trough Plasma Cysteamine Concentration
Year 1
|
0.37 mg/L
Standard Deviation 0.513
|
|
Trough Plasma Cysteamine Concentration
Year 1.5
|
0.48 mg/L
Standard Deviation 0.718
|
|
Trough Plasma Cysteamine Concentration
Year 2
|
0.36 mg/L
Standard Deviation 0.412
|
|
Trough Plasma Cysteamine Concentration
Year 3
|
0.34 mg/L
Standard Deviation 0.659
|
|
Trough Plasma Cysteamine Concentration
Year 4
|
0.47 mg/L
Standard Deviation 0.708
|
|
Trough Plasma Cysteamine Concentration
Year 5
|
0.40 mg/L
Standard Deviation 0.399
|
SECONDARY outcome
Timeframe: Day 1 (predose) and Month 6, Years 1, 1.5, 2, 3, 4 and 5 at 0.5 hours post-dosePopulation: The Pharmacokinetic/Pharmacodynamic (PK/PD) Population includes all participants who had at least one PK/PD measurement. Day 1 results only include participants who did not complete Study RP103-03.
White blood cell (WBC) cystine concentration was determined using high performance liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS).
Outcome measures
| Measure |
Cysteamine Bitartrate
n=59 Participants
Cysteamine bitartrate delayed-release capsules were administered twice daily for up to 96 months.
|
|---|---|
|
White Blood Cell Cystine Concentration
Day 1
|
1.68 nmol 1/2 Cystine/mg protein
Standard Deviation 1.275
|
|
White Blood Cell Cystine Concentration
Month 6
|
0.93 nmol 1/2 Cystine/mg protein
Standard Deviation 1.174
|
|
White Blood Cell Cystine Concentration
Year 1
|
0.65 nmol 1/2 Cystine/mg protein
Standard Deviation 0.569
|
|
White Blood Cell Cystine Concentration
Year 1.5
|
0.75 nmol 1/2 Cystine/mg protein
Standard Deviation 0.852
|
|
White Blood Cell Cystine Concentration
Year 2
|
0.65 nmol 1/2 Cystine/mg protein
Standard Deviation 0.851
|
|
White Blood Cell Cystine Concentration
Year 3
|
0.66 nmol 1/2 Cystine/mg protein
Standard Deviation 0.575
|
|
White Blood Cell Cystine Concentration
Year 4
|
1.38 nmol 1/2 Cystine/mg protein
Standard Deviation 1.672
|
|
White Blood Cell Cystine Concentration
Year 5
|
1.17 nmol 1/2 Cystine/mg protein
Standard Deviation 2.117
|
Adverse Events
Cysteamine Bitartrate
Serious events: 32 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cysteamine Bitartrate
n=59 participants at risk
Cysteamine bitartrate delayed-release capsules were administered twice daily for up to 96 months.
|
|---|---|
|
Infections and infestations
Appendicitis
|
11.9%
7/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Gastroenteritis
|
10.2%
6/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Appendicitis perforated
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Bacterial diarrhoea
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Otitis media chronic
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Pneumonia
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Pyelonephritis
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Respiratory tract infection viral
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Salpingitis
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Tooth abscess
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Urethritis
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Renal and urinary disorders
Renal failure chronic
|
6.8%
4/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Renal and urinary disorders
Renal failure
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Renal and urinary disorders
Renal failure acute
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Renal and urinary disorders
Renal impairment
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Renal and urinary disorders
Renal tubular acidosis
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
4/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
2/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Gastric fistula
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Peritonitis
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.5%
5/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.8%
4/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Metabolism and nutrition disorders
Acidosis
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
8.5%
5/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Injury, poisoning and procedural complications
Graft dysfunction
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Investigations
Biopsy kidney
|
3.4%
2/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Investigations
Investigation
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.4%
2/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Congenital, familial and genetic disorders
Arnold-chiari malformation
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Psychiatric disorders
Abnormal behavior
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Psychiatric disorders
Impaired self-care
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Psychiatric disorders
Mental disorder
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
General disorders
Impaired healing
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Immune system disorders
Kidney transplant rejection
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Nervous system disorders
Convulsion
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Nervous system disorders
Epilepsy
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Nervous system disorders
Loss of consciousness
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Nervous system disorders
Pseudoparalysis
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Surgical and medical procedures
Nephrectomy
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Surgical and medical procedures
Postoperative care
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Vascular disorders
Hypertension
|
1.7%
1/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
Other adverse events
| Measure |
Cysteamine Bitartrate
n=59 participants at risk
Cysteamine bitartrate delayed-release capsules were administered twice daily for up to 96 months.
|
|---|---|
|
Infections and infestations
Molluscum contagiosum
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Pharyngitis
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Rhinitis
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Tonsillitis
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Varicella
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Viral infection
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Nervous system disorders
Headache
|
37.3%
22/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Nervous system disorders
Syncope
|
8.5%
5/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Nervous system disorders
Lethargy
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
General disorders
Fatigue
|
16.9%
10/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
General disorders
Pyrexia
|
13.6%
8/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
General disorders
Asthenia
|
6.8%
4/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
General disorders
Influenza like illness
|
6.8%
4/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
General disorders
Oedema peripheral
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
General disorders
Pain
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.9%
10/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.3%
9/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.8%
4/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.9%
10/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.5%
5/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.5%
5/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
6.8%
4/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
10.2%
6/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Eye disorders
Conjunctivitis
|
23.7%
14/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Eye disorders
Photophobia
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.2%
6/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.5%
5/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Investigations
Blood creatinine increased
|
8.5%
5/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
6.8%
4/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Vascular disorders
Hypertension
|
11.9%
7/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Immune system disorders
Seasonal allergy
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Psychiatric disorders
Depression
|
8.5%
5/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.8%
4/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Vomiting
|
67.8%
40/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.8%
17/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Nausea
|
27.1%
16/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
20.3%
12/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Breath odour
|
13.6%
8/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.9%
7/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Constipation
|
6.8%
4/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Flatulence
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.1%
3/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Influenza
|
23.7%
14/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Nasopharyngitis
|
22.0%
13/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Gastroenteritis
|
18.6%
11/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Ear infection
|
16.9%
10/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.9%
10/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Sinusitis
|
10.2%
6/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Urinary tract infection
|
10.2%
6/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Bronchitis
|
8.5%
5/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
|
Infections and infestations
Otitis media
|
8.5%
5/59 • From first dose of study drug to 7 days after last dose; median duration of treatment was 1461 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Horizon requests that any investigator/institution that plans on presenting/publishing results provide written notification of their request 60 days prior to their presentation/publication. Horizon requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Horizon needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER