Trial Outcomes & Findings for Gefitinib, Trastuzumab, and Docetaxel in Treating Patients With Metastatic Breast Cancer (NCT NCT00086957)

NCT ID: NCT00086957

Last Updated: 2017-02-27

Results Overview

Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater except for hematological toxicities which must be grade 4. Interstitial Lung Disease (ILD) related to treatment should be considered as a DLT regardless of the grade.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: 4 weeks from start of treatment, up to 2 years
• Results posted on: 2017-02-27

Participant Flow

Participant milestones

Measure	Phase I - Docetaxel 75 mg/m^2 Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m\^2 intravenously every 3 weeks.	Phase I - Docetaxel 60 mg/m^2 Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m\^2 intravenously every 3 weeks.	Phase II - Docetaxel 60 mg/m^2 Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m\^2 intravenously every 3 weeks.
Overall Study STARTED	2	7	22
Overall Study COMPLETED	2	7	22
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gefitinib, Trastuzumab, and Docetaxel in Treating Patients With Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	Dose Levels 1 & 2 - Docetaxel 60 & 75 mg/m^2 n=31 Participants trastuzumab: Cycle 1 loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks for subsequent cycles. docetaxel: 75 mg/m\^2 every three weeks, or 60 mg/m\^2 every three weeks depending on study findings gefitinib: 250 mg daily or 250 mg daily on days 2 through 14 depending on study findings
Age, Continuous	52 years n=5 Participants
Gender Female	31 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks from start of treatment, up to 2 years

Population: All patients receiving treatment were evaluated for DLT.

Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater except for hematological toxicities which must be grade 4. Interstitial Lung Disease (ILD) related to treatment should be considered as a DLT regardless of the grade.

Outcome measures

Measure	Phase I: Dose Level 1 - Docetaxel 75 mg/m^2 n=2 Participants Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m\^2 intravenously every 3 weeks.	Phase I: Dose Level 2 - Docetaxel 60 mg/m^2 n=7 Participants Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m\^2 intravenously every 3 weeks.
Number of Participants With at Least One Dose Limiting Toxicity in Phase I	2 participants with DLTs	0 participants with DLTs

PRIMARY outcome

Timeframe: 4 weeks from start of treatment, up to 2 years

Population: All patients observed for 21 days while receiving a full course of therapy or who experienced a DLT. Patients withdrawing before completion of the first course, for reasons other than DLT, were replaced.

The maximum tolerated dose (MTD): subjects received gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m^2 intravenously every 3 weeks. This was to serve as the phase II dose if no dose-limiting toxicities (DLTs) occurred in the first three subjects. If one DLT occurred in the first three subjects, another three subjects where to be enrolled at this dose, whereas if two DLTs occurred in the first three subjects, the docetaxel dose was to be decreased to 60 mg/m^2. The study would then be continued only if no more than one patient had a DLT at this dose. Once the dose of docetaxel was established, all further subjects were to be treated at the phase II MTD dose.

Outcome measures

Measure	Phase I: Dose Level 1 - Docetaxel 75 mg/m^2 n=9 Participants Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m\^2 intravenously every 3 weeks.	Phase I: Dose Level 2 - Docetaxel 60 mg/m^2 Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m\^2 intravenously every 3 weeks.
Recommended Phase II Dose	60 mg/m^2	—

SECONDARY outcome

Timeframe: Until disease progression, up to 5 years.

Population: All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion).

Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.

Outcome measures

Measure	Phase I: Dose Level 1 - Docetaxel 75 mg/m^2 n=29 Participants Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m\^2 intravenously every 3 weeks.	Phase I: Dose Level 2 - Docetaxel 60 mg/m^2 Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m\^2 intravenously every 3 weeks.
Progression-free Survival	12.7 Months Interval 7.6 to 21.8	—

SECONDARY outcome

Timeframe: After 3 cycles of treatment, up to 2 years.

Population: All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion). Patients who complete 3 cycles of treatment or who terminate treatment for reasons of toxicity, or who progress prior to the completion of 3 cycles of therapy on the Phase II portion of the study.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate defined as percentage of patients achieving a Best Response of either CR or PR.

Outcome measures

Measure	Phase I: Dose Level 1 - Docetaxel 75 mg/m^2 n=29 Participants Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m\^2 intravenously every 3 weeks.	Phase I: Dose Level 2 - Docetaxel 60 mg/m^2 Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m\^2 intravenously every 3 weeks.
Objective Response Rate	64 percentage of participants	—

SECONDARY outcome

Timeframe: Until death from any cause, up to 5 years.

Population: All patients treated at the phase II docetaxel dose (7 in the phase I portion, 22 in the phase II portion).

Estimated using the product-limit method of Kaplan and Meier.

Outcome measures

Measure	Phase I: Dose Level 1 - Docetaxel 75 mg/m^2 n=29 Participants Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m\^2 intravenously every 3 weeks.	Phase I: Dose Level 2 - Docetaxel 60 mg/m^2 Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m\^2 intravenously every 3 weeks.
Overall Survival	43.2 Months Interval 30.8 to 65.3	—

Adverse Events

Dose Level 1 - Docetaxel 75 mg/m^2

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Dose Level 2 - Docetaxel 60 mg/m^2

Serious events: 7 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dose Level 1 - Docetaxel 75 mg/m^2 n=2 participants at risk Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m\^2 intravenously every 3 weeks.	Dose Level 2 - Docetaxel 60 mg/m^2 n=29 participants at risk Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m\^2 intravenously every 3 weeks.
Blood and lymphatic system disorders Febrile neutropenia	100.0% 2/2 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Haemorrhage NOS	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Melaena	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Catheter related infection	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection NOS	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukopenia	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/29 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/29 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Measure	Dose Level 1 - Docetaxel 75 mg/m^2 n=2 participants at risk Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m\^2 intravenously every 3 weeks.	Dose Level 2 - Docetaxel 60 mg/m^2 n=29 participants at risk Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m\^2 intravenously every 3 weeks.
Gastrointestinal disorders Haematemesis	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Hemoglobin decreased	100.0% 2/2 • Number of events 9 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	86.2% 25/29 • Number of events 196 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Lymphatic disorder	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.0% 9/29 • Number of events 18 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Blood and lymphatic system disorders Packed red blood cell transfusion	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Arrhythmia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Cardiac disorder	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Left ventricular failure	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.2% 5/29 • Number of events 8 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Myocardial ischemia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.3% 3/29 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Palpitations	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus bradycardia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	100.0% 2/2 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.6% 8/29 • Number of events 24 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Ear disorder	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Ear pain	50.0% 1/2 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.3% 3/29 • Number of events 4 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders External ear inflammation	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Ear and labyrinth disorders Hearing loss	50.0% 1/2 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Endocrine disorders Hypothyroidism	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/29 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Dry eye syndrome	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Eye disorder	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.8% 4/29 • Number of events 7 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Vision blurred	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Eye disorders Watering eyes	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.3% 3/29 • Number of events 4 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.6% 8/29 • Number of events 18 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.7% 6/29 • Number of events 16 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	100.0% 2/2 • Number of events 5 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	89.7% 26/29 • Number of events 129 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dry mouth	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.3% 3/29 • Number of events 9 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Esophagitis	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/29 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastritis	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.3% 3/29 • Number of events 4 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorder	50.0% 1/2 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.0% 9/29 • Number of events 44 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Melaena	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	100.0% 2/2 • Number of events 4 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	51.7% 15/29 • Number of events 32 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	100.0% 2/2 • Number of events 5 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	62.1% 18/29 • Number of events 44 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 8 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal bleeding/hematochezia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 4 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.9% 11/29 • Number of events 17 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chest pain	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.3% 3/29 • Number of events 10 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	100.0% 2/2 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.6% 8/29 • Number of events 12 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	100.0% 2/2 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	96.6% 28/29 • Number of events 158 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.9% 11/29 • Number of events 17 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders General symptom	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.3% 3/29 • Number of events 5 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Injection site reaction	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Oedema NOS	100.0% 2/2 • Number of events 5 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.7% 6/29 • Number of events 9 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	100.0% 2/2 • Number of events 5 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	55.2% 16/29 • Number of events 60 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Hepatobiliary disorders Hepatobiliary disease	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Immune system disorders Hypersensitivity	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Immune system disorders Immune system disorder	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.3% 3/29 • Number of events 4 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection	50.0% 1/2 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.2% 5/29 • Number of events 7 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection NOS	50.0% 1/2 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.0% 9/29 • Number of events 15 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection with unknown ANC	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection without neutropenia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.3% 3/29 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection, Viral (COH)	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Wound infection	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Bruising	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Injury, poisoning and procedural complications Intraoperative gastrointestinal injury - Teeth	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.7% 6/29 • Number of events 45 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	50.0% 1/2 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	86.2% 25/29 • Number of events 97 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	48.3% 14/29 • Number of events 30 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Amylase increased	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	100.0% 2/2 • Number of events 5 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	86.2% 25/29 • Number of events 150 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Bilirubin increased	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.8% 4/29 • Number of events 4 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyperbilirubinemia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hypercholesterolemia	50.0% 1/2 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations INR increased	100.0% 2/2 • Number of events 4 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	48.3% 14/29 • Number of events 92 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Laboratory test abnormal	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.0% 9/29 • Number of events 26 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukocyte count decreased	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	41.4% 12/29 • Number of events 65 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukopenia	100.0% 2/2 • Number of events 6 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	55.2% 16/29 • Number of events 103 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	44.8% 13/29 • Number of events 93 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphopenia	100.0% 2/2 • Number of events 5 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	41.4% 12/29 • Number of events 107 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	100.0% 2/2 • Number of events 4 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	82.8% 24/29 • Number of events 142 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.2% 5/29 • Number of events 5 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight gain	50.0% 1/2 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	24.1% 7/29 • Number of events 26 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	50.0% 1/2 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.0% 9/29 • Number of events 20 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Acidosis	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.6% 8/29 • Number of events 15 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood bicarbonate decreased	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.2% 5/29 • Number of events 6 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood glucose increased	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.9% 11/29 • Number of events 42 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood uric acid increased	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.3% 3/29 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.2% 5/29 • Number of events 8 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	44.8% 13/29 • Number of events 53 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypertriglyceridemia	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.8% 4/29 • Number of events 7 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 2/2 • Number of events 4 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	44.8% 13/29 • Number of events 55 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypocalcemia	100.0% 2/2 • Number of events 5 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.9% 11/29 • Number of events 30 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.3% 3/29 • Number of events 4 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	100.0% 2/2 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	34.5% 10/29 • Number of events 29 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.0% 9/29 • Number of events 22 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.2% 5/29 • Number of events 5 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypophosphatemia	100.0% 2/2 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	48.3% 14/29 • Number of events 54 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum albumin decreased	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.6% 8/29 • Number of events 25 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium decreased	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.7% 6/29 • Number of events 8 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium increased	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.3% 3/29 • Number of events 8 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum glucose decreased	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum magnesium decreased	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	24.1% 7/29 • Number of events 25 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum magnesium increased	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum phosphate decreased	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.7% 6/29 • Number of events 15 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum potassium decreased	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	34.5% 10/29 • Number of events 23 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum sodium decreased	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Bone pain	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.6% 8/29 • Number of events 19 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Joint pain	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.8% 4/29 • Number of events 4 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.2% 5/29 • Number of events 5 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.6% 8/29 • Number of events 12 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.2% 5/29 • Number of events 16 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Ataxia	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/29 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	100.0% 2/2 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.2% 5/29 • Number of events 10 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	50.0% 1/2 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	34.5% 10/29 • Number of events 22 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Neuralgia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.2% 5/29 • Number of events 7 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Neurological disorder NOS	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.7% 6/29 • Number of events 7 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.0% 9/29 • Number of events 26 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Syncope	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Taste alteration	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.6% 8/29 • Number of events 11 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	34.5% 10/29 • Number of events 13 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	24.1% 7/29 • Number of events 9 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Personality change	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Bladder pain	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	17.2% 5/29 • Number of events 6 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Protein urine positive	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary frequency	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary retention	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urine discoloration	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urogenital disorder	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.3% 3/29 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Reproductive tract disorder	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Vaginal dryness	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Reproductive system and breast disorders Vaginal inflammation	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.8% 4/29 • Number of events 6 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Cough	100.0% 2/2 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	41.4% 12/29 • Number of events 36 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 1/2 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	41.4% 12/29 • Number of events 27 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.8% 4/29 • Number of events 5 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.0% 9/29 • Number of events 21 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Voice alteration	50.0% 1/2 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.8% 4/29 • Number of events 6 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.0% 9/29 • Number of events 24 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.9% 11/29 • Number of events 16 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	24.1% 7/29 • Number of events 15 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pigmentation changes (e.g., vitiligo)	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pruritus	50.0% 1/2 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.0% 9/29 • Number of events 9 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash desquamating	100.0% 2/2 • Number of events 5 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	82.8% 24/29 • Number of events 77 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Skin disorder	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	41.4% 12/29 • Number of events 30 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Flushing	50.0% 1/2 • Number of events 2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.8% 4/29 • Number of events 9 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hemorrhage	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hot flashes	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.9% 2/29 • Number of events 3 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	50.0% 1/2 • Number of events 5 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	10.3% 3/29 • Number of events 4 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypotension	50.0% 1/2 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	24.1% 7/29 • Number of events 8 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Thrombosis	0.00% 0/2 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	3.4% 1/29 • Number of events 1 • Adverse events occurred over a period of 5 years and 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 626-359-8111

Email: pfrankel@coh.org

Results disclosure agreements

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