Adverse Event Clinical Research
1.0.1 - STU1

Adverse Event Clinical Research, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-ig/ and changes regularly. See the Directory of published versions

## Cancer Clinical Trial Example

# Cancer Clinical Trial Adverse Event Research Study Medications

Patient Kaitlyn B. is a 36 year old non-Hispanic white female with a past medical history significant for asthma. Her family history was significant for a mother and maternal aunt both with breast cancer diagnosed premenopausal. Both are alive and well presently. She also has a deceased paternal grandfather from non small cell lung carcinoma (NSCLC).

During a routine screening mammography in May 8, 2019, an abnormality was detected as a possible mass and suspected breast cancer (Birads 4). A ultrasound was done (5/9/2019) followed by an ultrasound biopsy of the left breast mass which measured 3.0cm on imaging. Pathology confirmed a diagnosis of high grade invasive ductal carcinoma (IDC) that was ER Negative at 0%; PR Negative at 0% and HER2 Positive 3+ by IHC. There were no suspicious lymph nodes seen on imaging. The patient is referred to an oncologist who clinically reviewed (5/17/21) the history, imaging and pathology results. Physical exam shows about a 3cm palpable mass in the left breast thus the patient is clinically staged as cT3N0. She was to receive neoadjuvant chemotherapy of Taxol 175mg/m2 as well as Pertuzumab and Trastuzumab for a total of 6 cycles. Each cycle is 21 days. Start date 5/20/2019 for cycle 1 (c2 was 6/10/19, c3 was 7/3/19, c4 was 7/22/19, c5 was 8/12/19 and cycle 6 was 9/2/19 (for start of that last three week cycle)). She completed treatment on 9/23/2019 without significant issues and no dose reductions or holding and was scheduled for surgery per her General Surgeon.

A left partial mastectomy was performed on December 3, 2019 with sentinel lymph node dissection, revealing residual disease with a 2.1 cm tumor without lymph-vascular invasion and negative margins of excision. Three sentinel lymph nodes were excised were negative. The pathology report revealed a 2.8cm malignant tumor histological grade 3/3 invasive ductal carcinoma with prognostic tumor markers ER negative 0%, PR negative 0%, and HER2 Positive/3+ by IHC. The patient is pathologically staged as pT3 pN0 M0, stage group IIA. A 21-gene RT-PCR assay yielded a recurrence score of 29.

Patient was seen by her oncologist on 3/12/20 in follow up after surgery and after the completion of 4 weeks of post operative radiation therapy to the left chest (radiation start date was 1/30/20 and end date was 2/27/20). Treatment options were discussed between the patient and the medical oncologist and the patient consented on 3/12/20 to treatment on the Alliance Compass Protocol A011801. She presently has an ECOG performance score of 0. She is to receive 14 four cycles of Kadcyla IV at 3.6mg every 21 days with oral Tucatinib 300mg twice a day every day.

She began her first cycle of Kadcyla and started on Tucatinib on 4/1/2020. She tolerated cycle well. On 4/22/20 she arrived for cycle 2. Her lab work was all within normal limits except for an alanine aminotransferase (ALT) increased at 50 (grade 1 per CTCAE v 5.0) This is considered probably related to both drugs. Patient seen in 3 weeks for cycle 2. Lab work stable. On cycle 3 (5/13/20) she arrived and was noted to have an increased ALT to 200 U/L. This was grade 3 and probably related to one or both drugs. No other lab abnormalities noted. Treatment was held today per protocol guidelines and the patient was scheduled to return in one week for repeat lab work. She was seen on 5/20/20 and her ALT was decreased down to 60 which was grade 1 level - OK to proceed with treatment and restart oral medication. Kadcyla was dose reduced to 3.0mg and the Tucatinib was also dose reduced to 250mg twice daily per dose reduction guidelines in protocol. Cycle 4 was then on 6/10/20 and patient c/o Nausea/vomiting grade 1 throughout this past cycle starting about 5/25/20. This was attributed as possibly related to Kadcyla and probably related to Tucatinib and is ongoing. Additional antiemetics were prescribed on 6/10/20 (Zofran 8mg orally every 6-8 hours as needed). Her ALT value was WNL and the adverse event was considered resolved on 6/10/20. She continued on treatment and completed the total of 14 cycles on 01/27/21 without further dose reductions or adverse events (chemo dates - C5: 7/1/20, C6: 7/22/20, C7: 8/12/20, C8: 9/02/20, C9: 9/23/20, C10: 10/14/20, C11: 11/04/20, C12: 11/25/20, C13: 12/16/20, C14: 01/06/21). She will be seen in f/u as per standard of care.

For simplicity, this example covers the Patient’s journey starting with the Alliance clinical trial Compass, the events within the red box in the timeline.

Links to the adverse event examples:

- Example AdverseEvent 1
- Example AdverseEvent 1a
- Example AdverseEvent 1b
- Example AdverseEvent 2