Trial Outcomes & Findings for Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer (NCT NCT00295893)

Last Updated: 2025-09-25

Results Overview

pCR was defined as no evidence of residual invasive cancer (or very few scattered tumor cells) in primary tumor and lymph nodes.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

121 participants

Primary outcome timeframe

At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months

Results posted on

2025-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Patients receive 50mg/m2 doxorubicin hydrochloride IV, 500 mg/m2 cyclophosphamide IV, and 75 mg/m2 docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin Patients receive 60 mg/m2 doxorubicin hydrochloride IV and 600 mg/m2 cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive AUC 2 carboplatin IV on day 1 and 100 mg/m2 paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab Patients receive chemotherapy as in arm II. They also receive 2 mg/kg trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.
Overall Study STARTED	37	40	44
Overall Study COMPLETED	37	40	44
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide n=37 Participants Patients receive 50 mg/m2 doxorubicin hydrochloride IV, 500 mg/m2 cyclophosphamide IV, and 75 mg/m2 docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin n=40 Participants Patients receive 60 mg/m2 doxorubicin hydrochloride IV and 600 mg/m2 cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive AUC 2 carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and 100 mg/m2 paclitaxel repeats every 4 weeks for 3 courses.	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab n=44 Participants Patients receive chemotherapy as in arm II. They also receive 2 mg/kg trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.	Total n=121 Participants Total of all reporting groups
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants	13 Participants n=4 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized White	19 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants	55 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic	14 Participants n=5 Participants	19 Participants n=7 Participants	12 Participants n=5 Participants	45 Participants n=4 Participants
Region of Enrollment United States	37 participants n=5 Participants	40 participants n=7 Participants	44 participants n=5 Participants	121 participants n=4 Participants
Age, Continuous	50 years n=5 Participants	49 years n=7 Participants	52 years n=5 Participants	50 years n=4 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	40 Participants n=7 Participants	44 Participants n=5 Participants	121 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized American Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months

pCR was defined as no evidence of residual invasive cancer (or very few scattered tumor cells) in primary tumor and lymph nodes.

Outcome measures

Outcome measures
Measure	Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide n=37 Participants Patients receive 50 mg/m2 doxorubicin hydrochloride IV, 500 mg/m2 cyclophosphamide IV, and 75 mg/m2 docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin n=40 Participants Patients receive 60 mg/m2 doxorubicin hydrochloride IV and 600 mg/m2 cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive AUC 2 carboplatin IV on day 1 and 100 mg/m2 paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab n=44 Participants Patients receive chemotherapy as in arm II. They also receive 2 mg/m2 trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.
Count of Patients With Pathologic Complete Response (pCR)	6 Participants	4 Participants	22 Participants

PRIMARY outcome

Timeframe: At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months.

RCB score is determined using information on the size of the tumor and the extent of tumor cells in the breast and axillary lymph nodes after neoadjuvant therapy. The higher the RCB score, the more residual breast cancer there is in the breast and lymph nodes: RCB-0 = No residual breast cancer RCB-I = Small amount of residual breast cancer RCB-II = Moderate amount of residual breast cancer RCB-III = Extensive (a lot of) residual breast cancer

Outcome measures

Outcome measures
Measure	Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide n=37 Participants Patients receive 50 mg/m2 doxorubicin hydrochloride IV, 500 mg/m2 cyclophosphamide IV, and 75 mg/m2 docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin n=40 Participants Patients receive 60 mg/m2 doxorubicin hydrochloride IV and 600 mg/m2 cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive AUC 2 carboplatin IV on day 1 and 100 mg/m2 paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab n=44 Participants Patients receive chemotherapy as in arm II. They also receive 2 mg/m2 trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.
Count of Patients With Residual Cancer Burden (RCB) Scores of 0 or 1.	11 Participants	10 Participants	28 Participants

Adverse Events

Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide

Serious events: 8 serious events

Other events: 37 other events

Deaths: 2 deaths

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin

Serious events: 5 serious events

Other events: 40 other events

Deaths: 4 deaths

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab

Serious events: 8 serious events

Other events: 44 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 626-218-5265

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide n=37 participants at risk Patients receive 50 mg/m2 doxorubicin hydrochloride IV, 500 mg/m2 cyclophosphamide IV, and 75 mg/m2 docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin n=40 participants at risk Patients receive 60 mg/m2 doxorubicin hydrochloride IV and 600 mg/m2 cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive AUC 2 carboplatin IV on day 1 and 100 mg/m2 paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab n=44 participants at risk Patients receive chemotherapy as in arm II. They also receive 2 mg/m2 trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.
Blood and lymphatic system disorders Febrile neutropenia	13.5% 5/37 • Number of events 5 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Cardiac pain	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Pericarditis	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 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% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 2/44 • Number of events 2 • Adverse events occurred over a period of 2 years and 7 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% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chest pain	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 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% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	2.7% 1/37 • Number of events 2 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Bronchitis	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Pancreas infection	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Skin infection	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.8% 3/44 • Number of events 3 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Soft tissue infection	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Upper aerodigestive tract infection	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Upper respiratory infection	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Urinary tract infection	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 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% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukocyte count decreased	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lipase increased	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	5.4% 2/37 • Number of events 3 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 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% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 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	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 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% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 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% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 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% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Cognitive disturbance	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Depressed level of consciousness	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 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% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 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% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 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% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Psychosis	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 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	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 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	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.0% 2/40 • Number of events 2 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 2/44 • Number of events 2 • Adverse events occurred over a period of 2 years and 7 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	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events
Measure	Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide n=37 participants at risk Patients receive 50 mg/m2 doxorubicin hydrochloride IV, 500 mg/m2 cyclophosphamide IV, and 75 mg/m2 docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses.	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin n=40 participants at risk Patients receive 60 mg/m2 doxorubicin hydrochloride IV and 600 mg/m2 cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive AUC 2 carboplatin IV on day 1 and 100 mg/m2 paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses.	Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab n=44 participants at risk Patients receive chemotherapy as in arm II. They also receive 2 mg/m2 trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin.
Immune system disorders Hypersensitivity	5.4% 2/37 • Number of events 2 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 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% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Bronchitis	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Conjunctivitis infective	2.7% 1/37 • Number of events 2 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Eye infection	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.0% 2/40 • Number of events 2 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Infection	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 4/44 • Number of events 5 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Otitis media	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Peripheral nerve infection	2.7% 1/37 • Number of events 2 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 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 neurological injury - NERVES: Peripheral sensory NOS	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 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 Wound dehiscence	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.0% 2/40 • Number of events 3 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 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	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	67.6% 25/37 • Number of events 62 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	62.5% 25/40 • Number of events 77 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	77.3% 34/44 • Number of events 110 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	27.0% 10/37 • Number of events 26 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	40.0% 16/40 • Number of events 53 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	45.5% 20/44 • Number of events 68 • Adverse events occurred over a period of 2 years and 7 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% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	83.8% 31/37 • Number of events 109 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	92.5% 37/40 • Number of events 143 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	84.1% 37/44 • Number of events 145 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Coagulopathy	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.0% 2/40 • Number of events 3 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Forced expiratory volume decreased	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Haptoglobin decreased	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 2/44 • Number of events 2 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Hyperbilirubinemia	2.7% 1/37 • Number of events 2 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Laboratory test abnormal	5.4% 2/37 • Number of events 2 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.5% 3/40 • Number of events 4 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukocyte count decreased	37.8% 14/37 • Number of events 37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	67.5% 27/40 • Number of events 73 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	68.2% 30/44 • Number of events 86 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukopenia	21.6% 8/37 • Number of events 43 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 8/40 • Number of events 24 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	9.1% 4/44 • Number of events 12 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	8.1% 3/37 • Number of events 11 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	30.0% 12/40 • Number of events 32 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.3% 12/44 • Number of events 44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphopenia	16.2% 6/37 • Number of events 33 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	15.0% 6/40 • Number of events 29 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	11.4% 5/44 • Number of events 15 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	51.4% 19/37 • Number of events 73 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	72.5% 29/40 • Number of events 66 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	72.7% 32/44 • Number of events 70 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	48.6% 18/37 • Number of events 57 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	45.0% 18/40 • Number of events 33 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	36.4% 16/44 • Number of events 34 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Serum cholesterol increased	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.8% 3/44 • Number of events 4 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight gain	16.2% 6/37 • Number of events 15 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	7.5% 3/40 • Number of events 3 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	15.9% 7/44 • Number of events 11 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight loss	16.2% 6/37 • Number of events 11 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	22.5% 9/40 • Number of events 25 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.8% 14/44 • Number of events 30 • Adverse events occurred over a period of 2 years and 7 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	16.2% 6/37 • Number of events 10 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	27.5% 11/40 • Number of events 15 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	36.4% 16/44 • Number of events 30 • Adverse events occurred over a period of 2 years and 7 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	10.8% 4/37 • Number of events 5 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 3 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 2/44 • Number of events 2 • Adverse events occurred over a period of 2 years and 7 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	67.6% 25/37 • Number of events 75 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	37.5% 15/40 • Number of events 47 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	31.8% 14/44 • Number of events 59 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Pharyngitis	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.5% 1/40 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Rhinitis infective	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Sinusitis	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.0% 2/40 • Number of events 2 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/44 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Skin infection	2.7% 1/37 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	5.0% 2/40 • Number of events 2 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	6.8% 3/44 • Number of events 3 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Tooth infection	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	2.3% 1/44 • Number of events 1 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Upper aerodigestive tract infection	0.00% 0/37 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	0.00% 0/40 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	4.5% 2/44 • Number of events 4 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Upper respiratory infection	5.4% 2/37 • Number of events 3 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	20.0% 8/40 • Number of events 8 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.	13.6% 6/44 • Number of events 7 • Adverse events occurred over a period of 2 years and 7 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.