TriangleNCT02400476 · OUTCOME
Percentage of Patients With Serious Adverse Events and Other Adverse Events of Special Interest
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose of investigational product through 28 days after last dose, up to 15.5 months.
What was measured
Assess the percentage of patients with serious adverse events (SAEs) and other adverse events of special interest (AESI). AESIs were selected based on the known safety profile of neratinib as well as typical key body system toxicity concerns generally reviewed for any new drug. These AESIs were grouped into the following categories: gastrointestinal toxicity (diarrhea and stomatitis), hepatotoxicity, pulmonary toxicity (interstitial lung disease), cardiac toxicity (LVEF decreased), and dermatologic toxicity (rash and nail disorders). The AESIs were analyzed by searching the clinical database for all TEAEs and SAEs using either Standardized MedDRA Queries (SMQs) or, if an applicable SMQ did not exist, a Sponsor-defined list of MedDRA preferred terms.
Analysis population: All subjects who received at least one dose of neratinib.
Groups in this outcome
Loperamide
240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed. Neratinib Loperamide
Budesonide and Loperamide
240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Anti-inflammatory treatment for 1 cycle and Loperamide to be administered daily for two 28-day cycles and then as needed, thereafter. Neratinib Loperamide Budesonide: 9 mg extended release tablets once daily with or without food for 28 days
Colestipol and Loperamide
240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered 1 cycle and then as needed, thereafter. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle
Colestipol With Loperamide as Needed
240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle
Neratinib Dose Escalation 1
120 mg Neratinib for Week 1, followed by 160 mg Neratinib starting for Week 2, followed by 240 mg Neratinib starting at Week 3 and thereafter (C1D15 to End of Treatment). Loperamide administered as needed. Neratinib Loperamide
Neratinib Dose Escalation 2
160 mg neratinib for the first 2 weeks, followed by 200 mg neratinib for the next 2 weeks, followed by 240 mg neratinib thereafter (C2D1 to End of treatment. Loperamide will be administered on an as-needed basis only. Neratinib Loperamide
| Group | Source count |
|---|---|
| Loperamide | 137 |
| Budesonide and Loperamide | 64 |
| Colestipol and Loperamide | 136 |
| Colestipol With Loperamide as Needed | 104 |
| Neratinib Dose Escalation 1 | 60 |
| Neratinib Dose Escalation 2 | 62 |
Reported measurements
Percentage of Patients with SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Loperamide | 6.57 | Not reported | Not reported | Not reported | Not reported |
| Budesonide and Loperamide | 6.25 | Not reported | Not reported | Not reported | Not reported |
| Colestipol and Loperamide | 6.62 | Not reported | Not reported | Not reported | Not reported |
| Colestipol With Loperamide as Needed | 2.88 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 1 | 8.33 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 2 | 8.06 | Not reported | Not reported | Not reported | Not reported |
Percentage of Patients with AESI-Gastrointestinal Toxicities (Diarrhoea and Stomatitis Broad Search)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Loperamide | 81.75 | Not reported | Not reported | Not reported | Not reported |
| Budesonide and Loperamide | 87.5 | Not reported | Not reported | Not reported | Not reported |
| Colestipol and Loperamide | 83.82 | Not reported | Not reported | Not reported | Not reported |
| Colestipol With Loperamide as Needed | 96.15 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 1 | 98.33 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 2 | 98.39 | Not reported | Not reported | Not reported | Not reported |
Percentage of Patients with-Hepatotoxicities SMQ (Broad Search)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Loperamide | 12.41 | Not reported | Not reported | Not reported | Not reported |
| Budesonide and Loperamide | 7.81 | Not reported | Not reported | Not reported | Not reported |
| Colestipol and Loperamide | 4.41 | Not reported | Not reported | Not reported | Not reported |
| Colestipol With Loperamide as Needed | 4.81 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 1 | 8.33 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 2 | 4.84 | Not reported | Not reported | Not reported | Not reported |
Percentage of Patients with AESI- Interstitial Lung Disease SMQ (Broad Search)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Loperamide | 0 | Not reported | Not reported | Not reported | Not reported |
| Budesonide and Loperamide | 0 | Not reported | Not reported | Not reported | Not reported |
| Colestipol and Loperamide | 0 | Not reported | Not reported | Not reported | Not reported |
| Colestipol With Loperamide as Needed | 0 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 2 | 0 | Not reported | Not reported | Not reported | Not reported |
Percentage of Patients with AESI-Cardiac Toxicities SMQ (Broad Search)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Loperamide | 5.84 | Not reported | Not reported | Not reported | Not reported |
| Budesonide and Loperamide | 6.25 | Not reported | Not reported | Not reported | Not reported |
| Colestipol and Loperamide | 10.29 | Not reported | Not reported | Not reported | Not reported |
| Colestipol With Loperamide as Needed | 7.69 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 1 | 10.00 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 2 | 4.84 | Not reported | Not reported | Not reported | Not reported |
Percentage of Patients with AESI - Dermatologic Toxicities (Rash and Nail Disorders)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Loperamide | 12.41 | Not reported | Not reported | Not reported | Not reported |
| Budesonide and Loperamide | 37.50 | Not reported | Not reported | Not reported | Not reported |
| Colestipol and Loperamide | 23.53 | Not reported | Not reported | Not reported | Not reported |
| Colestipol With Loperamide as Needed | 18.27 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 1 | 11.67 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 2 | 30.65 | Not reported | Not reported | Not reported | Not reported |
Percentage of Patients with AESI-Gastrointestinal Toxicities (Narrow Search)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Loperamide | 80.29 | Not reported | Not reported | Not reported | Not reported |
| Budesonide and Loperamide | 85.94 | Not reported | Not reported | Not reported | Not reported |
| Colestipol and Loperamide | 83.09 | Not reported | Not reported | Not reported | Not reported |
| Colestipol With Loperamide as Needed | 95.19 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 1 | 98.33 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 2 | 98.39 | Not reported | Not reported | Not reported | Not reported |
Percentage of Patients with AESI-Hepatotoxicities SMQ (Narrow Search)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Loperamide | 10.95 | Not reported | Not reported | Not reported | Not reported |
| Budesonide and Loperamide | 7.81 | Not reported | Not reported | Not reported | Not reported |
| Colestipol and Loperamide | 3.68 | Not reported | Not reported | Not reported | Not reported |
| Colestipol With Loperamide as Needed | 3.85 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 1 | 8.33 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 2 | 4.84 | Not reported | Not reported | Not reported | Not reported |
Percentage of Patients with AESI- Interstitial Lung Disease SMQ (Narrow Search)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Loperamide | 0 | Not reported | Not reported | Not reported | Not reported |
| Budesonide and Loperamide | 0 | Not reported | Not reported | Not reported | Not reported |
| Colestipol and Loperamide | 0 | Not reported | Not reported | Not reported | Not reported |
| Colestipol With Loperamide as Needed | 0 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 2 | 0 | Not reported | Not reported | Not reported | Not reported |
Percentage of Patients with AESI-Cardiac Toxicities SMQ (Narrow Search)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Loperamide | 2.92 | Not reported | Not reported | Not reported | Not reported |
| Budesonide and Loperamide | 0 | Not reported | Not reported | Not reported | Not reported |
| Colestipol and Loperamide | 1.47 | Not reported | Not reported | Not reported | Not reported |
| Colestipol With Loperamide as Needed | 0.96 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 1 | 1.67 | Not reported | Not reported | Not reported | Not reported |
| Neratinib Dose Escalation 2 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6.57
- group Id
- OG001
- value
- 6.25
- group Id
- OG002
- value
- 6.62
- group Id
- OG003
- value
- 2.88
- group Id
- OG004
- value
- 8.33
- group Id
- OG005
- value
- 8.06
- title
- Percentage of Patients with SAEs
- categories
- measurements
- group Id
- OG000
- value
- 81.75
- group Id
- OG001
- value
- 87.5
- group Id
- OG002
- value
- 83.82
- group Id
- OG003
- value
- 96.15
- group Id
- OG004
- value
- 98.33
- group Id
- OG005
- value
- 98.39
- title
- Percentage of Patients with AESI-Gastrointestinal Toxicities (Diarrhoea and Stomatitis Broad Search)
- categories
- measurements
- group Id
- OG000
- value
- 12.41
- group Id
- OG001
- value
- 7.81
- group Id
- OG002
- value
- 4.41
- group Id
- OG003
- value
- 4.81
- group Id
- OG004
- value
- 8.33
- group Id
- OG005
- value
- 4.84
- title
- Percentage of Patients with-Hepatotoxicities SMQ (Broad Search)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Percentage of Patients with AESI- Interstitial Lung Disease SMQ (Broad Search)
- categories
- measurements
- group Id
- OG000
- value
- 5.84
- group Id
- OG001
- value
- 6.25
- group Id
- OG002
- value
- 10.29
- group Id
- OG003
- value
- 7.69
- group Id
- OG004
- value
- 10.00
- group Id
- OG005
- value
- 4.84
- title
- Percentage of Patients with AESI-Cardiac Toxicities SMQ (Broad Search)
- categories
- measurements
- group Id
- OG000
- value
- 12.41
- group Id
- OG001
- value
- 37.50
- group Id
- OG002
- value
- 23.53
- group Id
- OG003
- value
- 18.27
- group Id
- OG004
- value
- 11.67
- group Id
- OG005
- value
- 30.65
- title
- Percentage of Patients with AESI - Dermatologic Toxicities (Rash and Nail Disorders)
- categories
- measurements
- group Id
- OG000
- value
- 80.29
- group Id
- OG001
- value
- 85.94
- group Id
- OG002
- value
- 83.09
- group Id
- OG003
- value
- 95.19
- group Id
- OG004
- value
- 98.33
- group Id
- OG005
- value
- 98.39
- title
- Percentage of Patients with AESI-Gastrointestinal Toxicities (Narrow Search)
- categories
- measurements
- group Id
- OG000
- value
- 10.95
- group Id
- OG001
- value
- 7.81
- group Id
- OG002
- value
- 3.68
- group Id
- OG003
- value
- 3.85
- group Id
- OG004
- value
- 8.33
- group Id
- OG005
- value
- 4.84
- title
- Percentage of Patients with AESI-Hepatotoxicities SMQ (Narrow Search)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Percentage of Patients with AESI- Interstitial Lung Disease SMQ (Narrow Search)
- categories
- measurements
- group Id
- OG000
- value
- 2.92
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1.47
- group Id
- OG003
- value
- 0.96
- group Id
- OG004
- value
- 1.67
- group Id
- OG005
- value
- 0
- title
- Percentage of Patients with AESI-Cardiac Toxicities SMQ (Narrow Search)
- denoms
- counts
- group Id
- OG000
- value
- 137
- group Id
- OG001
- value
- 64
- group Id
- OG002
- value
- 136
- group Id
- OG003
- value
- 104
- group Id
- OG004
- value
- 60
- group Id
- OG005
- value
- 62
- units
- Participants
- description
- Assess the percentage of patients with serious adverse events (SAEs) and other adverse events of special interest (AESI). AESIs were selected based on the known safety profile of neratinib as well as typical key body system toxicity concerns generally reviewed for any new drug. These AESIs were grouped into the following categories: gastrointestinal toxicity (diarrhea and stomatitis), hepatotoxicity, pulmonary toxicity (interstitial lung disease), cardiac toxicity (LVEF decreased), and dermatologic toxicity (rash and nail disorders). The AESIs were analyzed by searching the clinical database for all TEAEs and SAEs using either Standardized MedDRA Queries (SMQs) or, if an applicable SMQ did not exist, a Sponsor-defined list of MedDRA preferred terms.
- groups
- description
- 240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed. Neratinib Loperamide
- id
- OG000
- title
- Loperamide
- description
- 240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Anti-inflammatory treatment for 1 cycle and Loperamide to be administered daily for two 28-day cycles and then as needed, thereafter. Neratinib Loperamide Budesonide: 9 mg extended release tablets once daily with or without food for 28 days
- id
- OG001
- title
- Budesonide and Loperamide
- description
- 240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered 1 cycle and then as needed, thereafter. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle
- id
- OG002
- title
- Colestipol and Loperamide
- description
- 240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle
- id
- OG003
- title
- Colestipol With Loperamide as Needed
- description
- 120 mg Neratinib for Week 1, followed by 160 mg Neratinib starting for Week 2, followed by 240 mg Neratinib starting at Week 3 and thereafter (C1D15 to End of Treatment). Loperamide administered as needed. Neratinib Loperamide
- id
- OG004
- title
- Neratinib Dose Escalation 1
- description
- 160 mg neratinib for the first 2 weeks, followed by 200 mg neratinib for the next 2 weeks, followed by 240 mg neratinib thereafter (C2D1 to End of treatment. Loperamide will be administered on an as-needed basis only. Neratinib Loperamide
- id
- OG005
- title
- Neratinib Dose Escalation 2
- param Type
- NUMBER
- population Description
- All subjects who received at least one dose of neratinib.
- reporting Status
- POSTED
- time Frame
- From first dose of investigational product through 28 days after last dose, up to 15.5 months.
- title
- Percentage of Patients With Serious Adverse Events and Other Adverse Events of Special Interest
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice