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Trial Outcomes & Findings for Ibrutinib and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma (NCT NCT02744612)

NCT ID: NCT02744612

Last Updated: 2025-03-26

Results Overview

Complete response is defined based on Cheson criteria \[Cheson BD, Fisher RI, Barrington SF, et al: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification. Journal of Clinical Oncology 32:3059-3067, 2014\]. The complete response rate was calculated as the percent of evaluable patients that have confirmed CR; exact 95% confidence intervals was calculated for this estimate.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Up to 8 months.

Results posted on

2025-03-26

Participant Flow

Participant milestones

Participant milestones
Measure
Arm I: Ibrutinib 420 mg PO QD + BV 1.8 mg/kg IV Q21 Days
Patients receive ibrutinib 420 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Ibrutinib: Given PO
Arm II: Ibrutinib 560 mg PO QD + BV 1.8 mg/kg IV Q21 Days
Patients receive ibrutinib 560 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Ibrutinib: Given PO
Overall Study
STARTED
3
36
Overall Study
COMPLETED
3
34
Overall Study
NOT COMPLETED
0
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Arm I: Ibrutinib 420 mg PO QD + BV 1.8 mg/kg IV Q21 Days
Patients receive ibrutinib 420 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Ibrutinib: Given PO
Arm II: Ibrutinib 560 mg PO QD + BV 1.8 mg/kg IV Q21 Days
Patients receive ibrutinib 560 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Ibrutinib: Given PO
Overall Study
Withdrawal by Subject
0
2

Baseline Characteristics

Ibrutinib and Brentuximab Vedotin in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm I: Ibrutinib 420 mg PO QD + BV 1.8 mg/kg IV Q21 Days
n=3 Participants
Patients receive ibrutinib 420 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Ibrutinib: Given PO
Arm II: Ibrutinib 560 mg PO QD + BV 1.8 mg/kg IV Q21 Days
n=36 Participants
Patients receive ibrutinib 560 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Ibrutinib: Given PO
Total
n=39 Participants
Total of all reporting groups
Age, Continuous
34 years
n=99 Participants
33 years
n=107 Participants
33 years
n=206 Participants
Sex: Female, Male
Female
2 Participants
n=99 Participants
11 Participants
n=107 Participants
13 Participants
n=206 Participants
Sex: Female, Male
Male
1 Participants
n=99 Participants
25 Participants
n=107 Participants
26 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
16 Participants
n=107 Participants
16 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants
n=99 Participants
18 Participants
n=107 Participants
21 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
2 Participants
n=107 Participants
2 Participants
n=206 Participants
Region of Enrollment
United States
3 participants
n=99 Participants
36 participants
n=107 Participants
39 participants
n=206 Participants

PRIMARY outcome

Timeframe: Up to 8 months.

Population: 3 subjects didn't complete Cycle 1 and then were off treatment. So they are not evaluable for response.

Complete response is defined based on Cheson criteria \[Cheson BD, Fisher RI, Barrington SF, et al: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification. Journal of Clinical Oncology 32:3059-3067, 2014\]. The complete response rate was calculated as the percent of evaluable patients that have confirmed CR; exact 95% confidence intervals was calculated for this estimate.

Outcome measures

Outcome measures
Measure
Arm I: Ibrutinib 420 mg PO QD + BV 1.8 mg/kg IV Q21 Days
n=3 Participants
Patients receive ibrutinib 420 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Ibrutinib: Given PO
Arm II: Ibrutinib 560 mg PO QD + BV 1.8 mg/kg IV Q21 Days
n=33 Participants
Patients receive ibrutinib 560 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Ibrutinib: Given PO
Complete Response (CR) Rate
0 percent of participants
Interval 0.0 to 71.0
36 percent of participants
Interval 20.0 to 55.0

SECONDARY outcome

Timeframe: Up to 8 months

The overall response rate was calculated as the percent of evaluable patients that have confirmed complete response (CR) or partial response (PR); exact 95% confidence intervals will be calculated for this estimate. CR and PR are defined based on Cheson criteria \[Cheson BD, Fisher RI, Barrington SF, et al: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification. Journal of Clinical Oncology 32:3059-3067, 2014\].

Outcome measures

Outcome measures
Measure
Arm I: Ibrutinib 420 mg PO QD + BV 1.8 mg/kg IV Q21 Days
n=3 Participants
Patients receive ibrutinib 420 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Ibrutinib: Given PO
Arm II: Ibrutinib 560 mg PO QD + BV 1.8 mg/kg IV Q21 Days
n=33 Participants
Patients receive ibrutinib 560 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Ibrutinib: Given PO
Overall Response Rate (ORR)
33 percent of participants
Interval 1.0 to 91.0
67 percent of participants
Interval 48.0 to 82.0

Adverse Events

Arm I: Ibrutinib 420 mg PO QD + BV 1.8 mg/kg IV Q21 Days

Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths

Arm II: Ibrutinib 560 mg PO QD + BV 1.8 mg/kg IV Q21 Days

Serious events: 10 serious events
Other events: 36 other events
Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure
Arm I: Ibrutinib 420 mg PO QD + BV 1.8 mg/kg IV Q21 Days
n=3 participants at risk
Patients receive ibrutinib 420 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Ibrutinib: Given PO
Arm II: Ibrutinib 560 mg PO QD + BV 1.8 mg/kg IV Q21 Days
n=36 participants at risk
Patients receive ibrutinib 560 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Ibrutinib: Given PO
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Gastrointestinal disorders
Colitis
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Gastrointestinal disorders
Diarrhea
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
General disorders
Fever
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Infections and infestations
Infections and infestations - Other, specify
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Infections and infestations
Upper respiratory infection
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Dehydration
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Nervous system disorders
Syncope
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.

Other adverse events

Other adverse events
Measure
Arm I: Ibrutinib 420 mg PO QD + BV 1.8 mg/kg IV Q21 Days
n=3 participants at risk
Patients receive ibrutinib 420 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Ibrutinib: Given PO
Arm II: Ibrutinib 560 mg PO QD + BV 1.8 mg/kg IV Q21 Days
n=36 participants at risk
Patients receive ibrutinib 560 mg PO QD on days 1-21 and brentuximab vedotin 1.8 mg/kg IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Ibrutinib: Given PO
Blood and lymphatic system disorders
Anemia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
41.7%
15/36 • Number of events 29 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Cardiac disorders
Atrial fibrillation
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Cardiac disorders
Cardiac disorders - Other, specify
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 5 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Cardiac disorders
Chest pain - cardiac
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Cardiac disorders
Heart failure
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Cardiac disorders
Palpitations
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Cardiac disorders
Sinus bradycardia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Cardiac disorders
Sinus tachycardia
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
16.7%
6/36 • Number of events 11 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Cardiac disorders
Ventricular arrhythmia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Ear pain
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Tinnitus
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Vertigo
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Eye disorders
Eye disorders - Other, specify
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 4 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Abdominal distension
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Abdominal pain
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
36.1%
13/36 • Number of events 17 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Bloating
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Colitis
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Constipation
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
36.1%
13/36 • Number of events 15 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Diarrhea
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
63.9%
23/36 • Number of events 38 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Dry mouth
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
19.4%
7/36 • Number of events 7 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Dyspepsia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
27.8%
10/36 • Number of events 13 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Dysphagia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Flatulence
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Gastritis
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Gastroesophageal reflux disease
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
13.9%
5/36 • Number of events 5 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Gastrointestinal disorders - Other, specify
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
25.0%
9/36 • Number of events 16 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Gastrointestinal pain
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Hemorrhoidal hemorrhage
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Ileus
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Lower gastrointestinal hemorrhage
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Mucositis oral
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
13.9%
5/36 • Number of events 7 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Nausea
66.7%
2/3 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
69.4%
25/36 • Number of events 42 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Oral pain
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Stomach pain
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
13.9%
5/36 • Number of events 9 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Ear and labyrinth disorders
Vomiting
33.3%
1/3 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
41.7%
15/36 • Number of events 26 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
General disorders
Chills
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
25.0%
9/36 • Number of events 9 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
General disorders
Edema face
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
General disorders
Edema limbs
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
13.9%
5/36 • Number of events 5 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
General disorders
Edema trunk
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
General disorders
Fatigue
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
52.8%
19/36 • Number of events 34 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
General disorders
Fever
66.7%
2/3 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
38.9%
14/36 • Number of events 15 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
General disorders
General disorders and administration site conditions - Other, specify
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
11.1%
4/36 • Number of events 7 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
General disorders
Infusion related reaction
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
19.4%
7/36 • Number of events 13 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
General disorders
Localized edema
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
11.1%
4/36 • Number of events 4 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
General disorders
Malaise
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
General disorders
Multi-organ failure
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
General disorders
Non-cardiac chest pain
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
16.7%
6/36 • Number of events 8 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
General disorders
Pain
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
19.4%
7/36 • Number of events 8 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Immune system disorders
Allergic reaction
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Infections and infestations
Bronchial infection
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Infections and infestations
Infections and infestations - Other, specify
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Infections and infestations
Lung infection
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Infections and infestations
Rhinitis infective
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Infections and infestations
Sinusitis
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
8.3%
3/36 • Number of events 3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Infections and infestations
Skin infection
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Infections and infestations
Upper respiratory infection
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Infections and infestations
Urinary tract infection
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
11.1%
4/36 • Number of events 5 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Infections and infestations
Vaginal infection
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Injury, poisoning and procedural complications
Bruising
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Investigations
Activated partial thromboplastin time prolonged
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
16.7%
6/36 • Number of events 8 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Investigations
Alanine aminotransferase increased
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
44.4%
16/36 • Number of events 24 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Investigations
Alkaline phosphatase increased
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
13.9%
5/36 • Number of events 6 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Investigations
Aspartate aminotransferase increased
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
36.1%
13/36 • Number of events 18 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Investigations
Blood bilirubin increased
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 4 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Investigations
Cardiac troponin I increased
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Investigations
Creatinine increased
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Investigations
Lymphocyte count decreased
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
22.2%
8/36 • Number of events 11 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Investigations
Neutrophil count decreased
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
27.8%
10/36 • Number of events 21 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Investigations
Platelet count decreased
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
47.2%
17/36 • Number of events 25 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Investigations
Weight gain
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Investigations
Weight loss
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Investigations
White blood cell decreased
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
25.0%
9/36 • Number of events 18 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Alkalosis
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Anorexia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
36.1%
13/36 • Number of events 17 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Dehydration
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Glucose intolerance
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Hypercalcemia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Hyperglycemia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
25.0%
9/36 • Number of events 9 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Hyperkalemia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Hypermagnesemia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Hypernatremia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Hyperuricemia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
8.3%
3/36 • Number of events 3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Hypoalbuminemia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
19.4%
7/36 • Number of events 11 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Hypocalcemia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
13.9%
5/36 • Number of events 5 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Hypoglycemia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
27.8%
10/36 • Number of events 16 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Hypokalemia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
36.1%
13/36 • Number of events 23 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Hypomagnesemia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
16.7%
6/36 • Number of events 9 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Hyponatremia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
36.1%
13/36 • Number of events 18 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Hypophosphatemia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
30.6%
11/36 • Number of events 13 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Metabolism and nutrition disorders
Obesity
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Musculoskeletal and connective tissue disorders
Arthralgia
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
25.0%
9/36 • Number of events 15 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Musculoskeletal and connective tissue disorders
Back pain
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
8.3%
3/36 • Number of events 5 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Musculoskeletal and connective tissue disorders
Bone pain
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
22.2%
8/36 • Number of events 13 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
19.4%
7/36 • Number of events 9 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
13.9%
5/36 • Number of events 12 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
19.4%
7/36 • Number of events 11 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Nervous system disorders
Ataxia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Nervous system disorders
Dizziness
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
30.6%
11/36 • Number of events 20 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Nervous system disorders
Dysgeusia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Nervous system disorders
Headache
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
47.2%
17/36 • Number of events 29 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Nervous system disorders
Nervous system disorders - Other, specify
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Nervous system disorders
Neuralgia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Nervous system disorders
Paresthesia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Nervous system disorders
Peripheral motor neuropathy
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Nervous system disorders
Peripheral sensory neuropathy
33.3%
1/3 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
61.1%
22/36 • Number of events 48 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Nervous system disorders
Sinus pain
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Nervous system disorders
Somnolence
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Nervous system disorders
Tremor
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Psychiatric disorders
Agitation
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Psychiatric disorders
Anxiety
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
16.7%
6/36 • Number of events 8 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Psychiatric disorders
Confusion
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
8.3%
3/36 • Number of events 3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Psychiatric disorders
Delirium
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Psychiatric disorders
Depression
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Psychiatric disorders
Insomnia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
25.0%
9/36 • Number of events 16 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Psychiatric disorders
Psychiatric disorders - Other, specify
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Renal and urinary disorders
Acute kidney injury
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Renal and urinary disorders
Hematuria
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
16.7%
6/36 • Number of events 6 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Renal and urinary disorders
Proteinuria
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
22.2%
8/36 • Number of events 9 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Renal and urinary disorders
Renal and urinary disorders - Other, specify
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
8.3%
3/36 • Number of events 4 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Renal and urinary disorders
Urinary frequency
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Renal and urinary disorders
Urinary retention
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Renal and urinary disorders
Urinary tract pain
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Renal and urinary disorders
Urinary urgency
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Renal and urinary disorders
Urine discoloration
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Reproductive system and breast disorders
Menorrhagia
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 4 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Reproductive system and breast disorders
Vaginal hemorrhage
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Respiratory, thoracic and mediastinal disorders
Cough
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
19.4%
7/36 • Number of events 8 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Respiratory, thoracic and mediastinal disorders
Dyspnea
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
13.9%
5/36 • Number of events 6 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
8.3%
3/36 • Number of events 4 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Respiratory, thoracic and mediastinal disorders
Hoarseness
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
13.9%
5/36 • Number of events 5 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Respiratory, thoracic and mediastinal disorders
Postnasal drip
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
11.1%
4/36 • Number of events 4 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 5 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Respiratory, thoracic and mediastinal disorders
Sore throat
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
22.2%
8/36 • Number of events 12 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Skin and subcutaneous tissue disorders
Alopecia
33.3%
1/3 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
27.8%
10/36 • Number of events 13 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
8.3%
3/36 • Number of events 4 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Skin and subcutaneous tissue disorders
Erythroderma
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
5.6%
2/36 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
33.3%
12/36 • Number of events 15 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Skin and subcutaneous tissue disorders
Rash acneiform
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Skin and subcutaneous tissue disorders
Rash maculo-papular
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
41.7%
15/36 • Number of events 31 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Skin and subcutaneous tissue disorders
Scalp pain
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
16.7%
6/36 • Number of events 6 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Surgical and medical procedures
Surgical and medical procedures - Other, specify
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Vascular disorders
Flushing
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Vascular disorders
Hematoma
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Vascular disorders
Hot flashes
0.00%
0/3 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
2.8%
1/36 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Vascular disorders
Hypertension
33.3%
1/3 • Number of events 1 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
44.4%
16/36 • Number of events 38 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
Vascular disorders
Hypotension
66.7%
2/3 • Number of events 2 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.
11.1%
4/36 • Number of events 6 • From the time of the first study treatment up to 2 years post treatment, an average of 28 months.

Additional Information

Dr. Alex Herrera, MD

City of Hope Medical Center

Phone: 6263598111

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place