Trial Outcomes & Findings for Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer (NCT NCT00915018)
NCT ID: NCT00915018
Last Updated: 2018-08-22
Results Overview
Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
479 participants
Primary outcome timeframe
From randomization to disease progression or death, assessed up to 5.3 years
Results posted on
2018-08-22
Participant Flow
Participant milestones
| Measure |
Neratinib + Paclitaxel
Neratinib + Paclitaxel
Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
|
Trastuzumab + Paclitaxel
Trastuzumab + Paclitaxel
Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
|
|---|---|---|
|
Overall Study
STARTED
|
242
|
237
|
|
Overall Study
Received Treatment
|
240
|
234
|
|
Overall Study
COMPLETED
|
27
|
30
|
|
Overall Study
NOT COMPLETED
|
215
|
207
|
Reasons for withdrawal
| Measure |
Neratinib + Paclitaxel
Neratinib + Paclitaxel
Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
|
Trastuzumab + Paclitaxel
Trastuzumab + Paclitaxel
Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
|
|---|---|---|
|
Overall Study
Death
|
75
|
70
|
|
Overall Study
Lost to Follow-up
|
10
|
5
|
|
Overall Study
Withdrawal by Subject
|
38
|
27
|
|
Overall Study
By Sponsor due to Protocol Amendment
|
92
|
105
|
Baseline Characteristics
Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Neratinib + Paclitaxel
n=242 Participants
Neratinib + Paclitaxel
Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
|
Trastuzumab + Paclitaxel
n=237 Participants
Trastuzumab + Paclitaxel
Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
|
Total
n=479 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
199 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
392 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
54.3 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
54.1 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
242 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
479 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to disease progression or death, assessed up to 5.3 yearsPopulation: all randomized patients
Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy.
Outcome measures
| Measure |
Neratinib + Paclitaxel
n=242 Participants
Neratinib + Paclitaxel
Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
|
Trastuzumab + Paclitaxel
n=237 Participants
Trastuzumab + Paclitaxel
Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
|
|---|---|---|
|
Progression-Free Survival
|
12.9 months
Interval 11.1 to 14.9
|
12.9 months
Interval 11.1 to 14.8
|
SECONDARY outcome
Timeframe: From randomization to disease progression or last tumor assessment, assessed up to 5.3 yearsPopulation: all randomized patients
Defined as the percentage of subjects who achieved confirmed tumor response (complete or partial response) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-Progressive Disease for non-target lesions, and no new lesions.
Outcome measures
| Measure |
Neratinib + Paclitaxel
n=242 Participants
Neratinib + Paclitaxel
Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
|
Trastuzumab + Paclitaxel
n=237 Participants
Trastuzumab + Paclitaxel
Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
|
|---|---|---|
|
Objective Response Rate
|
74.8 percentage of participants
Interval 68.8 to 80.1
|
77.6 percentage of participants
Interval 71.8 to 82.8
|
SECONDARY outcome
Timeframe: From first response to first PD or death, assessed up to 5.3 years after first subject randomizedPopulation: patients who responded
Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, disease progression (PD), or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Outcome measures
| Measure |
Neratinib + Paclitaxel
n=181 Participants
Neratinib + Paclitaxel
Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
|
Trastuzumab + Paclitaxel
n=184 Participants
Trastuzumab + Paclitaxel
Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
|
|---|---|---|
|
Duration of Response
|
13.1 months
Interval 11.1 to 15.4
|
12.9 months
Interval 11.0 to 15.1
|
SECONDARY outcome
Timeframe: From randomization to disease progression or death, assessed up to 5.3 yearsPopulation: all randomized patients
Defined as the proportion of patients who achieved overall tumor response (CR or PR) or SD for at least 24 weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Neratinib + Paclitaxel
n=242 Participants
Neratinib + Paclitaxel
Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
|
Trastuzumab + Paclitaxel
n=237 Participants
Trastuzumab + Paclitaxel
Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
|
|---|---|---|
|
Clinical Benefit Rate
|
88.4 percentage of participants
Interval 83.7 to 92.2
|
85.2 percentage of participants
Interval 80.1 to 89.5
|
SECONDARY outcome
Timeframe: From randomization to disease progression PD or last tumor assessment, assessed up to 5.3 yearsPopulation: all randomized patients
Defined as the time interval from the date of randomization until the first date of CNS symptoms, the imaging examination shows CNS progression or is censored at the last assessable evaluation on study or prior to new anti-cancer therapy, if applicable. If median time to Symptomatic or Progressive CNS Lesions is not estimable, cumulative incidence will be reported instead.
Outcome measures
| Measure |
Neratinib + Paclitaxel
n=242 Participants
Neratinib + Paclitaxel
Neratinib: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
|
Trastuzumab + Paclitaxel
n=237 Participants
Trastuzumab + Paclitaxel
Trastuzumab: Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2 mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Paclitaxel: Paclitaxel - 80 mg/m2 IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
|
|---|---|---|
|
Symptomatic or Progressive Central Nervous System (CNS) Lesions
|
20 Participants
|
41 Participants
|
Adverse Events
Neratinib+Paclitaxel
Serious events: 67 serious events
Other events: 239 other events
Deaths: 0 deaths
Trastuzumab+Paclitaxel
Serious events: 56 serious events
Other events: 230 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neratinib+Paclitaxel
n=240 participants at risk
Neratinib + Paclitaxel
|
Trastuzumab+Paclitaxel
n=234 participants at risk
Trastuzumab + Paclitaxel
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.83%
2/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Cardiac disorders
Cardiac failure congestive
|
0.83%
2/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Cardiac disorders
Cardiac tamponade
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Cardiac disorders
Myocardial infarction
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Cardiac disorders
Pericardial effusion
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Eye disorders
Retinal degeneration
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Eye disorders
Uveitis
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.83%
2/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Ascites
|
0.83%
2/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
12/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
1.3%
3/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.83%
2/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Nausea
|
0.83%
2/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Volvulus
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
7/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
General disorders
Adhesion
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
General disorders
Disease progression
|
1.2%
3/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
General disorders
Fatigue
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
General disorders
Generalised oedema
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
General disorders
Multi-organ failure
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
General disorders
Oedema peripheral
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
General disorders
Pyrexia
|
1.2%
3/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
2.1%
5/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
General disorders
Sudden death
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
General disorders
Swelling
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Hepatobiliary disorders
Biliary colic
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Hepatobiliary disorders
Hepatic failure
|
0.83%
2/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Immune system disorders
Drug hypersensitivity
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Immune system disorders
Food allergy
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Immune system disorders
Type IV hypersensitivity reaction
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Appendicitis
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Candida infection
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Cellulitis
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
2.6%
6/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Dengue fever
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Device related infection
|
0.83%
2/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.85%
2/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Empyema
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Furuncle
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Gastroenteritis
|
1.2%
3/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Infection
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Lower respiratory tract infection
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Pleural infection
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Pneumonia
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Rash pustular
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Septic shock
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Staphylococcal infection
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.83%
2/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.83%
2/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
1.3%
3/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Injury, poisoning and procedural complications
Overdose
|
0.83%
2/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Investigations
Alanine aminotransferase increased
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Investigations
General physical condition abnormal
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Investigations
Weight decreased
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.85%
2/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
7/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
3/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.83%
2/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.83%
2/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
2.1%
5/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Nervous system disorders
Brain oedema
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Nervous system disorders
Cerebellar ischaemia
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Nervous system disorders
Coma
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Nervous system disorders
Headache
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Nervous system disorders
Transient ischaemic attack
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Psychiatric disorders
Confusional state
|
1.7%
4/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Renal and urinary disorders
Prerenal failure
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Renal and urinary disorders
Renal failure acute
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.85%
2/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.85%
2/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.85%
2/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.83%
2/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.43%
1/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Vascular disorders
Hypotension
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Vascular disorders
Shock
|
0.42%
1/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.00%
0/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
Other adverse events
| Measure |
Neratinib+Paclitaxel
n=240 participants at risk
Neratinib + Paclitaxel
|
Trastuzumab+Paclitaxel
n=234 participants at risk
Trastuzumab + Paclitaxel
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
31.2%
75/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
27.8%
65/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
30.0%
72/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
31.6%
74/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
13.3%
32/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
12.8%
30/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
32.1%
77/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
33.8%
79/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
16/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
1.7%
4/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
21.2%
51/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
11.1%
26/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
30/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
7.7%
18/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Constipation
|
14.6%
35/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
18.8%
44/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
92.5%
222/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
33.3%
78/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
12.9%
31/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
8.5%
20/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.7%
4/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
5.1%
12/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Nausea
|
44.6%
107/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
29.9%
70/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Stomatitis
|
24.6%
59/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
19.7%
46/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Gastrointestinal disorders
Vomiting
|
36.2%
87/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
15.8%
37/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
General disorders
Asthenia
|
22.1%
53/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
15.4%
36/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
General disorders
Fatigue
|
32.1%
77/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
27.4%
64/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
General disorders
Influenza like illness
|
4.2%
10/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
6.0%
14/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
General disorders
Oedema
|
4.6%
11/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
6.4%
15/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
General disorders
Oedema peripheral
|
14.2%
34/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
17.1%
40/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
General disorders
Pain
|
5.4%
13/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
5.6%
13/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
General disorders
Pyrexia
|
17.1%
41/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
18.8%
44/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Cystitis
|
5.4%
13/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
5.1%
12/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Influenza
|
4.6%
11/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
5.6%
13/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Nasopharyngitis
|
12.1%
29/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
14.1%
33/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Paronychia
|
6.7%
16/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
3.8%
9/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Rhinitis
|
0.83%
2/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
5.1%
12/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Upper respiratory tract infection
|
10.8%
26/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
13.7%
32/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Infections and infestations
Urinary tract infection
|
7.1%
17/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
6.4%
15/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Investigations
Alanine aminotransferase increased
|
12.9%
31/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
11.1%
26/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Investigations
Aspartate aminotransferase increased
|
10.8%
26/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
9.4%
22/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
15/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
4.7%
11/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Investigations
Weight decreased
|
15.8%
38/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
5.1%
12/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Investigations
Weight increased
|
3.3%
8/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
6.0%
14/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
31.7%
76/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
17.5%
41/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
7.5%
18/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
1.3%
3/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
5.4%
13/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
0.85%
2/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.8%
9/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
6.8%
16/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.9%
19/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
1.7%
4/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.6%
23/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
3.8%
9/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.2%
34/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
18.8%
44/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
37/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
11.5%
27/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.6%
11/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
5.1%
12/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
17/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
5.1%
12/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.4%
13/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
2.1%
5/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.4%
13/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
7.7%
18/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.9%
31/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
13.7%
32/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
30/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
10.7%
25/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Nervous system disorders
Dizziness
|
21.7%
52/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
12.8%
30/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Nervous system disorders
Dysgeusia
|
14.6%
35/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
6.8%
16/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Nervous system disorders
Headache
|
20.4%
49/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
19.2%
45/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Nervous system disorders
Hypoaesthesia
|
7.5%
18/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
10.7%
25/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Nervous system disorders
Neuropathy peripheral
|
25.4%
61/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
25.6%
60/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Nervous system disorders
Paraesthesia
|
8.8%
21/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
5.1%
12/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
19.6%
47/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
22.6%
53/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Psychiatric disorders
Insomnia
|
13.3%
32/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
12.0%
28/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Reproductive system and breast disorders
Breast pain
|
2.1%
5/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
5.1%
12/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
24/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
20.1%
47/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.7%
28/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
9.4%
22/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.0%
36/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
8.5%
20/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.5%
18/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
8.5%
20/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.5%
6/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
7.3%
17/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
52.5%
126/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
56.8%
133/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.8%
14/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
5.1%
12/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.8%
9/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
6.8%
16/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
13.8%
33/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
13.2%
31/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
5.8%
14/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
3.0%
7/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.9%
19/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
9.4%
22/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
72/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
21.8%
51/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Vascular disorders
Hot flush
|
5.4%
13/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
3.4%
8/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
|
Vascular disorders
Hypertension
|
5.4%
13/240 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
8.1%
19/234 • From First Dose through 28 days after last dose, assessed up to 5.3 years
|
Additional Information
Senior Director, Clinical Operations
Puma Biotechnology, Inc.
Phone: +1 (424) 248-6500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60